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Carlsbad, United States of America | Full time | Field-based | R1547446 Join a Team That’s Advancing Clinical Research We’re looking for a passionate and driven Clinical Research Associate (CRA) to join our team and play a key role in delivering high-quality clinical trials. In this role, you’ll partner with investigative sites and cross-functional teams to ensure studies are executed with excellence, compliance, and patient focus. What You’ll Do Lead and execute site monitoring visits (selection, initiation, routine, and close-out) in accordance with GCP/ICH guidelines Build strong relationships with investigative sites to drive performance, recruitment, and engagement Ensure protocol compliance, data integrity, and high-quality study execution Proactively identify risks, resolve issues, and escalate when needed Track and manage study progress, including regulatory approvals, enrollment, and data quality Maintain accurate documentation and contribute to inspection readiness Collaborate with cross-functional teams to ensure successful study delivery What You Bring Bachelor’s degree in life sciences, healthcare, or related field (or equivalent experience) 1+ year of on-site monitoring experience Solid understanding of GCP, ICH, and regulatory requirements Strong communication, problem-solving, and organizational skills Ability to manage multiple priorities in a fast-paced environment Why Join Us Make a direct impact on advancing clinical research and improving patient outcomes Work alongside experienced, collaborative teams Opportunities for growth and career development Dynamic, fast-paced environment where your contributions matter If you’re ready to take the next step in your CRA career and be part of meaningful, impactful work, we’d love to hear from you. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $87,200.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Carlsbad, United States of America | Full time | Field-based | R1547445 Join a Team That’s Advancing Clinical Research We’re looking for a passionate and driven Clinical Research Associate (CRA) to join our team and play a key role in delivering high-quality clinical trials. In this role, you’ll partner with investigative sites and cross-functional teams to ensure studies are executed with excellence, compliance, and patient focus. What You’ll Do Lead and execute site monitoring visits (selection, initiation, routine, and close-out) in accordance with GCP/ICH guidelines Build strong relationships with investigative sites to drive performance, recruitment, and engagement Ensure protocol compliance, data integrity, and high-quality study execution Proactively identify risks, resolve issues, and escalate when needed Track and manage study progress, including regulatory approvals, enrollment, and data quality Maintain accurate documentation and contribute to inspection readiness Collaborate with cross-functional teams to ensure successful study delivery What You Bring Bachelor’s degree in life sciences, healthcare, or related field (or equivalent experience) 1.5+ years of on-site monitoring experience Solid understanding of GCP, ICH, and regulatory requirements Strong communication, problem-solving, and organizational skills Ability to manage multiple priorities in a fast-paced environment Why Join Us Make a direct impact on advancing clinical research and improving patient outcomes Work alongside experienced, collaborative teams Opportunities for growth and career development Dynamic, fast-paced environment where your contributions matter If you’re ready to take the next step in your CRA career and be part of meaningful, impactful work, we’d love to hear from you. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $90,200.00 - $175,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. We are looking for a Manufacturing Engineer to join our multidisciplinary team, contributing to cutting-edge projects that drive innovation in healthcare and diagnostics. POSITION SUMMARY: The Manufacturing Engineer is a hands-on technical leader responsible for developing, improving, and sustaining manufacturing processes for regulated instruments and devices, including FDA Class II products. This role plays a critical part in driving operational excellence through built-in quality, lean manufacturing, structured new product introduction (NPI), and alignment with plant-level SQDC goals (Safety, Quality, Delivery, Cost). The ideal candidate thrives in a low- to mid-volume, high-mix environment and excels at cross-functional collaboration, process rigor, and systems thinking. ESSENTIAL FUNCTIONS: Process Development & Built-In Quality: Lead the design, development, validation, and implementation of robust assembly and test processes, including IQ/OQ/PQ and equipment qualification. Apply Built-in Quality principles to manufacturing line design, including: Single-piece flow where applicable Right-sized and ergonomically optimized workstations Task segmentation to reduce complexity and rework 5S workplace organization and visual controls Integration of poka-yoke (error-proofing) mechanisms Design and release work instructions, process documentation, and in-process controls to ensure repeatable and scalable manufacturing. Continuous Improvement & Lean Manufacturing: Drive continuous improvement initiatives using Lean tools (e.g., value stream mapping, standard work, visual management). Conduct time and motion studies, line balancing, and workstation optimization to improve efficiency and reduce waste. Support tier-based escalation and visual factory systems to monitor and resolve Safety, Quality, Delivery, and Cost (SQDC) issues on the floor. Implement data-driven process controls to reduce variability and increase yield. Lead root cause investigations and corrective actions (CAPA) to address systemic production issues. New Product Introduction (NPI) & Client Integration: Act as the manufacturing lead for NPI, owning process development and validation deliverables throughout the product lifecycle. Collaborate with R&D, client engineering, and internal stakeholders to ensure design-for-manufacturability (DFM), smooth design transfer, and process readiness. Define and execute NPI activities such as PFMEA, pilot build support, validation plans, and readiness reviews. Serve as the technical point of contact for client engagements, audits, and feedback loops related to manufacturability and scalability. Documentation, Change Control & Compliance: Maintain controlled documentation including work instructions, BOMs, test protocols, and validation records in accordance with ISO 13485 and FDA 21 CFR 820. Initiate and process Engineering Change Orders (ECOs) and Document Change Orders (DCOs) to ensure technical documentation is up to date and reflects approved changes. Ensure robust configuration control across drawings, specifications, and revision history. Own or support Nonconformance Reports (NCRs) by conducting root cause analysis, implementing containment and corrective actions, and collaborating with Quality and Production. Participate in or lead Material Review Boards (MRBs) to disposition nonconforming material and drive resolution. Cross-Functional Collaboration: Work closely with Quality, Supply Chain, Planning, and Production teams to resolve issues, implement improvements, and meet customer and regulatory requirements. Translate client product requirements into manufacturable solutions and operational procedures. Represent manufacturing in client meetings, audits, and design reviews. Leadership & Mentorship: Provide technical mentorship to junior engineers and manufacturing support staff. Lead Kaizen events, RCCA investigations, and continuous improvement initiatives across departments. Contribute to the development and tracking of engineering and production metrics in alignment with SQDC performance indicators. Support tier-based daily management systems to ensure timely escalation, resolution, and communication of key operational issues. EDUCATION, EXPERIENCE, SKILLS AND ABILITIES REQUIRED: Education & Experience: Typically requires 2+ years of experience, and a mechanical, electrical or industrial engineering Bachelor’s degree from four-year College or university, or the equivalent combination of education, experience and training that provides the required knowledge, skills and abilities. Job Complexity: Works on problems of diverse scope and high complexity, often with incomplete or ambiguous information. Requires in-depth analysis and a strong understanding of manufacturing systems, regulatory constraints, and client expectations. Exercises sound judgment in selecting methods, techniques, and evaluation criteria to develop scalable and compliant solutions. Independently drives initiatives while building strong internal and external relationships across engineering, quality, production, and client teams. Knowledge, Skills & Abilities: Knowledge of manufacturing principles including Lean, Built-in Quality, 5S, single-piece flow, poka-yoke, throughput, utilization, and process capability. Skilled in PFMEA, control plans, process validation (IQ/OQ/PQ), and test method development. Experienced with root cause analysis (8D, 5 Whys, fishbone), CAPA, SPC, Gage R&R, and risk-based quality tools. Proficient in interpreting mechanical drawings, GD&T, electrical schematics, and BOMs. Familiar with mechanical and electromechanical components (motors, gears, sensors, adhesives, fasteners, fluidic systems, optics systems, and PCBAs). Understanding of fabrication and assembly methods including machining, molding, welding, and surface treatments. Knowledge of FDA 21 CFR 820, ISO 13485, and regulatory compliance practices (CE, UL). Experience with ECOs, DCOs, NCRs, MRB, and configuration control processes. Ability to support NPI from prototype through production and engage directly with clients on design transfer and manufacturability. Effective in cross-functional collaboration and tiered issue escalation aligned with SQDC (Safety, Quality, Delivery, Cost) performance metrics. Proficient in CAD (SolidWorks preferred), ERP/document control systems, and MS Office; experience with test automation or simulation tools is a plus. Strong communication, problem-solving, presentation, and mentorship skills. EFFORT REQUIRED: Physical Activities: This position primarily requires the ability to sit at a desk and work on a computer for extended periods of time, including frequent use of a keyboard and other standard office equipment for written and electronic communication. The role occasionally involves walking through production areas, standing during inspections or meetings, and lifting objects up to 25 pounds. Telephone communication may also be required intermittently. The work environment includes both office and manufacturing floor settings, with a typical noise level that is moderate. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job. TRAVEL: This position may require some travel for up to 10% of the time. This is an on-site position in San Diego with an annual salary range of $90,000 - $110, 000, based on experience and qualifications Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Comfort starts with our 10,000+ team members across the globe, who are transforming the power of comfort every day. Our employees have the power to change lives, in our homes, work and communities. We foster an inclusive environment while honoring a legacy built on family, where everyone can be themselves. If you are ready to join an industry leading organization where our people are the most important asset, and innovation propels us into the future, you’re ready to take your seat at La-Z-Boy Incorporated. WE BELIEVE IN THE TRANSFORMATIONAL POWER OF COMFORT! Job Summary: Join our dynamic team and embark on a rewarding career where your ambition drives your success. Competitive earnings potential: includes an hourly base wage plus UNCAPPED commissions on all Sales. Responsible for creating sales utilizing exceptional customer service and knowledge of the La‐Z‐Boy selling process, products and services. Strive to create long‐term customer relationships that will lead to increased sales and profitability. Develop awareness of interior design through practical experience, observation and interaction with a La‐Z‐Boy Designer. Training Pay: $21 per hour for 2-6 weeks (no commissions) Average Annual Earning Potential After Training: $35,000 - $55,000+ (inclusive of base, bonus, and commission) Job Description: ✨ Sell Luxury. Live Modern. Earn Without Limits. ✨ Now Hiring: Sales Consultant – La-Z-Boy Furniture Galleries Location: Oceanside, CA Compensation: Base + Unlimited Commission La-Z-Boy isn’t just comfort — it’s modern, elevated, and unmistakably stylish. We’ve redefined the way people see furniture, and now we’re looking for someone who can match that energy on the sales floor. This is your chance to turn your natural charm, eye for design, and competitive drive into real results — and real income. What You’ll Be Doing: Guiding high-end clients through a premium sales experience. Creating inspired spaces with world-class furniture and décor. Curating luxury looks while earning commissions with no ceiling. What You’ll Get: Unlimited earnings– top performers take home $50K–$80K+ annually. A sleek, modern showroom that feels more like a gallery than a store. Ongoing training in luxury sales, interior trends, and design consultation. Exclusive employee discounts so your own space turns heads. A brand that sells itself — and a team that celebrates success. Who You Are: Polished, persuasive, and endlessly ambitious. Passionate about modern aesthetics and premium materials. Obsessed with detail, service, and delivering the wow factor. Experienced in sales or retail (luxury experience = a major plus). You don’t do average — and neither do we. This is your chance to turn your love for modern luxury into a high-reward career. Apply today. Curate beauty. Sell bold. Earn big. COMPENSATION for this location: Training Pay: $21.00 per hour for 2-6 weeks (no commission) After Training: Base pay $18.00 per hour + commission on written sales Commission: UNCAPPED commission on written sales - 3% on La-Z-Boy Design Sales and 2% on other sales, other than La-Z-Boy Design Sales. BENEFITS: Health Insurance through Blue Cross/Blue Shield Optum for Prescriptions In-Network Dental and Vision Insurance Paid Vacation 401k with match Disability Insurance Life Insurance and AD&D Paid Bonding Leave Paid Training Health Savings Account - Contributions go in tax-free, grow tax-free and are withdrawn tax-free Tuition Reimbursement (may receive up to $5,250 per calendar year) Employee Assistance Program (Free to all employees!) Counseling sessions Financial and legal resources KEY RESPONSIBILITIES (other duties as assigned): Drives Sales Contribute to store sales goals by selling furniture, accessories and services offered by La‐Z‐Boy Promote the Design program & assist the Designer to achieve established Design program sales goals Consistently execute the La‐Z‐Boy selling process and strive to provide a favorable experience to all customers. Develop and utilize sales skills and principals including approach, rapport building, needs discovery, customized portfolio presentations, answering objections, closing, follow‐up, after sale service and continuing contact with all previous and potential customers Maximize store promotions, marketing initiatives, and grassroots programs Maintain strong knowledge of the features and benefits of existing and new product lines Design Program Schedule professional home consultations to present customized room designs, including sample fabrics, furniture, tables and accessory recommendations as well as the benefits of a professional installation service. Execute and champion the Design process following the established company guidelines Responsible for supporting design related functions in the store Customer Focus Provide the highest level of customer service to all current and future customers Ensure that each La‐Z‐Boy customer has an informative and positive experience by using good customer service skills and knowledge of products, while following the company selling process Effectively use Podium to ensure customer satisfaction and future follow‐up Make sound business decisions to deliver customer satisfaction and promote team environment Provide support by being responsive to incoming phone calls and emails Assist in handling customer issues and/or complaints. Provide appropriate solutions and alternatives to the customer to achieve a satisfied experience People Maintain a positive working relationship with all store employees Assist to train, coach and develop new peers on La‐Z‐Boy product knowledge and selling process/skills to achieve store sales goals Help promote and champion a culture of sales and service Operational Excellence Assist with maintenance of the overall visual appearance of store, this includes but is not limited to maintaining floor and/or showroom displays, tagging products and accessories, maintaining accessory catalogs and design center fabrics, supporting floor moves, and maintaining general store cleanliness Accurately complete order information, collect deposits and fees, keep orderly customer records, and research customer payments and deliveries Responsible for accurately completing daily On‐Point system logs Show a sense of urgency, enthusiasm and excitement with the store team and customers Maintain adequate knowledge of company standards, product knowledge and internal processes and systems Consistently schedule deliveries with customers Responsible for opening and closing of the store MINIMUM REQUIREMENTS: High School Diploma or equivalent Previous selling experience and ability to close a sale strongly preferred Excellent communication, customer service skills, and organizational skills Strong interpersonal skills to effectively communicate, build rapport, and positively influence Demonstrated persuasion and negotiation skills Ability to effectively manage time and conflicting priorities Ability to effectively and productively with others as a team Ability to work the schedule and hours dictated by business needs Ability to work evenings, weekends and holidays as required Initiative to meet assigned goals, missions and objectives and motivated to achieve more Strong attention to detail Proficient in the use of Microsoft Office, including Word, Excel, Outlook and PowerPoint PREFERRED REQUIREMENTS: Bachelor’s degree in Business or a related field SUPERVISORY RESPONSIBILITIES: None PHYSICAL DEMANDS/WORK ENVIRONMENT: Ability to lift and/or carry up to 50 pounds. Ability to stand for long periods of time. Nearly continuous use of repetitive hand motions, hearing and listening. Often required to sit, walk, bend and stoop Subject to inside environmental conditions Ability to pass background and drug screen. OTHER DUTIES: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the incumbent for this job. Duties, responsibilities and activities may change at any time with or without notice. At La-Z-Boy, we prioritize clear communication and reward outstanding talent! We invite you to explore the exciting opportunities available. To help you make an informed decision, we’re sharing key information about our pay practices. What You Can Expect: Training Pay: $21 per hour for 2-6 weeks (no commission) Average Annual Earning Potential After Training: $35,000 - $55,000+ (inclusive of base, bonus, and commission) The company will not pay less than state/local minimum wage requirements Post-Training Pay: Base Pay: $18 per hour Commission & Bonus: Earn more with UNCAPPED commission on written sales - 3% on La-Z-Boy Design Sales and 2% on other sales, other than La-Z-Boy Design Sales. Quarterly bonus opportunity of $1,500, based on your ability to meet defined individual sales goals. Individual pay is based on various factors, including geographic location, personal performance and relevant qualifications, experience, and skills. By providing our salary ranges and compensation range details, we aim to foster understanding and confidence in our pay practices. Should the base rate plus the commissions earned during a performance period not be at or greater than location minimum wage requirements for the period, the company will make a minimum wage adjustment for the employee to be compliant with minimum wage for the location. Weekly Hours: 40 Benefits for Employees in the US: Benefit offerings to employees and their families include: Medical, Vision, Dental and Basic Life Insurance, available 401k retirement plan with company match of up to 6%. Paid time off includes: 9-11 paid holidays each year, two weeks’ prorated vacation as a new hire and either personal time (non-exempt only) or state mandated sick time. More information can be found via: https://learn.bswift.com/la-z-boy If this role requires travel / driving in order to perform the key responsibilities outlined above, candidates must be able to meet the qualifications noted in the company’s Driver Management Program to be considered for the role. At La-Z-Boy Incorporated, we're an equal opportunity employer. We understand that our employees’ diverse backgrounds, experiences, perspectives, and viewpoints add value to our ability to create and deliver the best possible service, quality products, and is of utmost importance as we work together to build comfort. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to fostering an environment in which all employees feel valued, included, and empowered to do their best work and bring great ideas to the table. If you are a qualified individual that may need a change or adjustment to the application/interviewing/hiring process as a result of your disability, you may request a reasonable accommodations by emailing our recruiting team at [email protected] or by calling 734-242-1444.
About the Opportunity Argen Corporation currently has an exciting opportunity for a Manufacturing Associate I to join a growing, technology-focused and service-oriented team. If you thrive in a fast- paced and dynamic environment and want to be a part of an organization with an unwavering commitment to quality dental solutions, then explore our career opportunities and get to know Argen. Schedule: Monday - Friday, 2nd Shift - 1:30PM - 10:00pm In this role, the successful candidate: Follow department work instructions and adhere to customer and industry standards for dental products. Adhere to work instructions to properly operate mechanical equipment as needed. Visually check medical devices and perform operations according to work instructions. Identify and recommend disposition of defective items for rework or scrap. Understand the product manufacturing process from initial steps through final inspection. Complete all documentation as required. Maintain a safe and clean work area. Cross training in one or more areas of manufacturing. What does it take to be successful? High school diploma or equivalent required. One plus years of experience working in a Manufacturing environment with minimal supervision preferred. Proficiency in one or more areas of Argen manufacturing. Ability to work in a team environment. Ability to follow instructions and readily accept additional responsibilities. Attention to detail and quality focused. Passionate about industry and desire to contribute where needed. Schedule adherence and dependability. Ability to meet tight deadlines and meet production goals. Ability to follow detailed directions in a manufacturing Good Manufacturing Practices (GMP) environment is required. Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training. Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred. Our Awesome Benefits! Medical, Dental and Vision Plans 401k with Employer Match Paid Time Off and Holidays Employee Events Wellness Programs Discounts for home, travel, entertainment and so much more! About Us Argen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing center that provides high quality dental solutions to dental labs of all sizes. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Argen continues to invest in innovative research and development, continually improving on our current products and developing new solutions for the dental industry. Argen provides our global customers with affordable, high-performance products and industry-leading customer service. Argen’s products are FDA regulated and ISO certified.
Position Summary The Quality Shift Manager oversees, directs, and ensures that all products manufactured during their shift meet food safety, regulatory and quality standards while providing real-time direction, accountability and decision making to support QA and Operations departments Schedule 1:00 PM - 9:30 PM Sunday-Thursday, with flexibility for OT on Friday's Essential Duties and Responsibilities Assures that the plant is compliant with GMP, SQF and HACCP plans and reports deficiencies or practices that could compromise food safety, quality and food defense. Responsible for but not limited to improving the effectiveness of the Quality Management System to better serve the business. Responsible for conducting quarterly performance reviews for QA staff, one-on-one meetings as necessary to address performance concerns, provide feedback and support retraining opportunities. Conducts preliminary review of CCP records, specifically HPP processing forms to ensure all product meets required critical parameters prior to packaging and release. Creates, reviews and maintains complete and accurate batch production records for all dietary supplement products. Oversee the verification of CPPs, allergen controls, labeling accuracy and quality parameters, by ensuring product meets in process specifications. Review monthly Quality audits for accuracy and deviations. Ensure corrective actions are taken. Manages out-of-spec results in real time along with initiating investigations, root cause analysis and dispositions on new and existing holds. Corrective action review and filing for all deviations in the plant. Develop and present monthly staff meetings covering key department, company and process updates, policy refreshers, data driven metrics, food safety topics. Additionally incorporates quiz segment to improve engagement and knowledge retention. Conducts cross-functional operational facility audits to identify deficiencies and submits necessary work orders to address the issues. Works with manufacturing and other team members to ensure plant activities and equipment installs pass quality and sanitation requirements. Covers for Floor Supervisors when needed. Ability to work every QA station and role if necessary. Promote a culture of accountability, engagement and continuous food safety awareness and improvement. Other tasks are requested by the QA manager. Ability to understand and follow verbal and written instructions related to safety, equipment operation, and daily work assignments. Maintain regular and reliable attendance. Job Qualifications B.S. Food Science, Microbiology or equivalent operations management experience. A minimum of 2 years in as a Managerial position in a manufacturing company. HACCP Certified. SQF practitioner certificate. Strong knowledge of food safety regulations. Other Skills & Abilities Excellent communication skills Strong computer proficiency Sharp critical thinking and problem-solving abilities Flexible and able to adapt to change Capable of working independently with moderate supervision Comfortable in a fast-paced production setting Language Skills Excellent verbal, written, and presentation communication skills required. Major Business/Professional Contacts Regular contact with corporate cross-functional partners, manufacturing Team Members, and the Leadership Team. Occasional contact with vendors. Working and Environmental Conditions Primarily works in an office environment with regular use of a computer, keyboard, and telephone. Occasionally required to work in the manufacturing environment, where temperatures may be around 35°F. Must be available for occasional evenings and weekends as needed. Physical Demands Ability to sit and/or stand for extended periods of time. Prolonged computer use, including light to heavy keyboard and screen time. Ability to lift and carry up to 50 lbs. Ability to push or pull up to 100 lbs. Requires extended periods of sitting and working at a computer screen. Compensation and Benefits Come thrive at Suja Life! We offer a competitive benefits package, including: Salary ranges from $75,000-90,000 Medical, dental, vision, life insurance, and more Paid Parental Leave – 12 Weeks at 100% Pay 401(k) match to help you plan for the future Paid time off: vacation, sick days & holidays Juice benefits: yes, we keep you fueled and refreshed! #ZR #INDHP Suja Life is proud to be an equal-opportunity employer seeking to create a welcoming and diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, ancestry, physical or mental disability, medical condition, marital status, genetics, age, or veteran status or any other applicable legally protected status or characteristic. The Company complies with all federal/local/state regulations regarding pay. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
The Quality Assurance Manager (QAM) will be responsible for product compliance with internal and customer requirements. These spans conception to completion. In addition, the QAM will develop, coordinate, improve, evaluate, and maintain the quality management system. Prior quality assurance experience and familiarity with industry standards (e.g. J-STD-001, IPC-A-600, IPC-A-610, IPC/WHMA-A-620, ISO9001, AS9100) is required. The QAM must have an aptitude and eagerness to learn, speak up when problems arise, and follow the process. They must be a self-starter with great time management skills and very strong attention to detail. Responsibilities Manage quality activities, including planning and monitoring technical performance, to ensure quality and financial objectives are met Lead and maintain the quality management system in compliance with AS9100 and applicable federal/state regulations Prepare and present QMS Management Review Provide leadership, mentoring, and development of a company-wide quality approach to daily activities Provide strategic quality leadership and serve as the primary quality representative for the leadership team Establish, monitor, and maintain quality objectives, metrics, and key performance indicators to drive continuous improvement activities Ensure effective corrective and preventive action, complaint handling, and nonconformance processing Participate in design reviews and review/approve documentation change orders Interface with external customers and suppliers Qualifications Bachelor's Degree in Engineering preferred Extensive knowledge of the AS9100 Quality Management Systems 10+ years of experience in the space or defense industry is required 5+ years of leadership experience overseeing quality systems is required Must be able to work on a self-initiated basis and in a team environment, and be able to work extended hours and travel as required. Must be a US Person (This position has export control and security-related requirements that mandate attention to the citizenship status of any potential candidate and necessitates that the individual either be a United States Citizen, Permanent Resident of the United States, or lawfully admitted into the United States as a refugee or granted asylum by the United States Government.) About Blue Marble Communications Blue Marble Communications designs and manufactures high-performance RF, free-space optical, and network communications modules and systems for deployment onboard satellites and other space vehicles. Our current product offerings include software-defined RF, microwave, and millimeter-wave modem/transceivers; optical laser communications terminals, Ethernet routers/switches, and systems comprised of combinations of these modules. BMC embraces a modern workplace culture and inclusive environment.
The Post-Market QA Specialist plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular diagnostic products. The ideal candidate will be responsible for monitoring and facilitating the handling of post-market complaints as well as ensuring compliance with applicable industry regulations, standards, and company policy. The role may support product complaint investigations, including lab testing, risk assessment and root cause analysis across Hologic’s global molecular diagnostic product lines. ESSENTIAL DUTIES AND RESPONSIBILITIES The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Complaint Handling and Investigation: Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR). Conduct initial assessments of complaints and work with cross-functional teams as needed to support timely investigation, root cause analysis, and resolution of complaints of moderate complexity Ensure timely, accurate, and complete complaint records in the complaint management system May support product complaint investigations, including lab testing, risk assessment, and root cause analysis as needed. Regulatory Reporting: Identify and escalate potential adverse events to QA management. Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements Ensure post-market activities are compliant with Hologic’s quality system and all applicable standards Data Analysis & Trending: Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues Audit & Inspection Support: Support internal and external audits related to post-market surveillance and complaint handling as needed Maintain accurate and audit-ready documentation. Training & Process Development: Contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance Train others as needed KNOWLEDGE Quality Systems: Working knowledge of post-market surveillance, complaint handling, risk management, and non-conformance / CAPA processes Compliance: Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and global post-market surveillance requirements Data Trending: Basic knowledge of tracking and trending product / process metrics and KPI’s with statistical methods and data visualization tools (e.g., Power BI), ideally for manufacturing or technical support of high volume products Product Knowledge: Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems SKILLS Communication: aptitude to clearly explain data, processes, compliance requirements to cross-functional audiences in meetings, presentations, and reports Organization: skilled at planning, executing, and managing tasks and processes to drive action individually and with others in a team setting Data Analysis: aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions BEHAVIORS Detail Oriented: proactively identifies and focuses on critical details needed to ensure accurate and high-quality results Inquisitive: strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others Quality / Safety Focused: committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts Resourceful: applies self-directed research, problem solving, critical thinking, collaboration skills to approach uncertainty and adapt to change REQUIREMENTS B.S. in scientific or engineering discipline 3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, complaint handling, and / or complaint trending. Prior experience supporting development and / or manufacturing of IVD or other medical device products preferred The annualized base salary range for this role is $71,000 - $104,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand. Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, apply today! #LI-AV1 Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
The QA Specialist II performs the day-to-day activities of the QA department to ensure drug substances manufactured by Bachem comply with FDA and international regulatory requirements for research, pre-clinical, clinical, and commercial purposes. Individuals in this position review and process assigned GMP documents, provide cGMP guidance to other departments, and provide support to customer and regulatory audits. Additionally, to manage (i.e. reconcile, issue, and maintain) GMP documents and records and, to provide support in document management electronic systems (e.g. MasterControl) What you will do Performs production room, dispensary and shipment clearance verifications, as required Revises established standard operating procedures (SOPs) as well as other GMP documents (e.g. stability protocols, raw material specifications, EM trend reports) as assigned Manages GMP documentation and their workflows as required by the department Verify scans of BPRs, chromatograms, etc. for accuracy and ensure documents are boxed, labeled correctly for archiving Coordinate, review and approval of quality events Training of new hires Provides support to regulatory, customer, and internal audits Drives continuous improvements and represents QA in process improvement project teams Implements and maintains Quality Management System Scan, verify and archive GMP records (internal and external) Review and/or approval of monitoring / trending data Represent QA in project teams (e.g. – harmonization of systems / processes across Bachem sites, implementation of new systems / processes) Qualifications Bachelor's Degree in organic chemistry or related field required or Master's Degree in organic chemistry or related field preferred Bachelor's Degree in Science or related field and a minimum of 3 years’ experience in a GMP / Manufacturing setting required or Associate's Degree in Science or related field and a minimum of 5 years' experience in the GMP/Manufacturing setting required 3-5 years experience in Quality Assurance and/or Quality Control required and 3-5 years experience in internal auditing as well as working with regulatory agencies required and 3-5 years experience working in ISO 7 and ISO 8 control environment and support real time batch record review required Ability to review scans of BPRs and chromatograms with high accuracy Knowledge of cGMP and FDA regulations and guidance(s). Knowledge of Quality Management Systems Knowledge of GxP Proficient computer knowledge, including Microsoft Word, Excel, and PowerPoint Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to work independently and manage one’s time Communicate effectively and ability to function well in a team environment Ability to troubleshoot and resolve problems Certified Quality Process Analyst - ASQ Preferred or CQA Preferred or CQE certification desired Preferred Base Annual Salary Range: $77,308.00-$96,635.00 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. Please note: unsolicited resumes from recruitment agencies will not be considered. Nearest Major Market: San Diego
Overview We are seeking a dedicated and detail-oriented Production Operator to join our dynamic team in Oceanside, CA, 92056. In this role, you will play a crucial part in our manufacturing process, ensuring that our products meet the highest quality standards. If you thrive in a fast-paced environment and enjoy working collaboratively, we want to hear from you! Position: Production Operator Hours: 4:45 am - 1:15 pm Monday - Friday Pay Rate: $20.50/hr Location" Oceanside, CA Responsibilities Operate and monitor production equipment to ensure efficient and safe operation. Perform quality checks on products and report any discrepancies to the supervisor. Maintain a clean and organized work area, adhering to safety and hygiene standards. Assist in troubleshooting equipment issues and perform minor repairs as needed. Collaborate with team members to meet production targets and deadlines. Document production data and maintain accurate records as required. Participate in training sessions and continuous improvement initiatives. Qualifications High school diploma or equivalent; technical certification is a plus. Previous experience in a manufacturing or production environment preferred. Strong attention to detail and ability to follow instructions accurately. Basic mechanical skills and problem-solving abilities. Ability to work effectively in a team and communicate clearly. Willingness to work flexible hours, including overtime if needed. Familiarity with safety protocols and procedures in a manufacturing setting.
Outstanding medical device components manufacturer has immediate openings for Quality Inspectors to join their team! The Quality Inspector I monitors the quality of incoming, in process, and outgoing products or materials for the Company. They are tasked with conducting tests, performing measurements, and auditing production processes. PRINCIPAL ACCOUNTABILITIES Able to utilize microscope, digital calipers, micrometer, optical comparator, vision measurement system, and other related equipment with optimal accuracy Have basic understanding of blueprints Provides in-process inspection Maintain proper inspection and test records Assures that non-conforming material has been properly identified Advises the responsible production personnel of acceptability of products or materials based on results of testing and/or inspection Maintains lot traceability, log sheets, and good housekeeping practices at all times Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner Proficient with computer applications ex. ERP system, document control systems, nonconforming product systems. Able to work overtime (including weekends) when needed SCOPE The Quality Inspector reports directly to the Quality Supervisor and is responsible for the inspection of incoming materials, work in process and finished goods in the production of machined parts to ensure conformance as defined by QSR/GMP, ISO 9001:2015 standard, customer specifications, and Company requirements. QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE High School diploma or equivalent 1 year minimum manufacturing work experience with demonstrated ability in inspection Must be able to utilize all hand tools, micrometers, optical comparator, and other related equipment with optimal accuracy. PERSONAL SKILLS AND KEY COMPETENCIES Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables Excellent communications skills, both oral and written Ability to motivate and work well with others Able to understand and follow directions Wear appropriate PPE on the Production Floor Participate in regular stretch breaks 1st shift: 6:00 am - 2:30 pm (1 opening) $19.50/hr 2nd shift (2:00 pm - 10:30 pm) (1 opening) $19.50/hr + 10% shift diff = *$21.45/hr.* ***In addition, Monthly Bonus on both shifts**** Please submit your resume for consideration. Pay: $19.50 - $21.45 per hour Work Location: In person
Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. We are looking for a Manufacturing Engineer to join our multidisciplinary team, contributing to cutting-edge projects that drive innovation in healthcare and diagnostics. POSITION SUMMARY: The Manufacturing Engineer is a hands-on technical leader responsible for developing, improving, and sustaining manufacturing processes for regulated instruments and devices, including FDA Class II products. This role plays a critical part in driving operational excellence through built-in quality, lean manufacturing, structured new product introduction (NPI), and alignment with plant-level SQDC goals (Safety, Quality, Delivery, Cost). The ideal candidate thrives in a low- to mid-volume, high-mix environment and excels at cross-functional collaboration, process rigor, and systems thinking. ESSENTIAL FUNCTIONS: Process Development & Built-In Quality: Lead the design, development, validation, and implementation of robust assembly and test processes, including IQ/OQ/PQ and equipment qualification. Apply Built-in Quality principles to manufacturing line design, including: Single-piece flow where applicable Right-sized and ergonomically optimized workstations Task segmentation to reduce complexity and rework 5S workplace organization and visual controls Integration of poka-yoke (error-proofing) mechanisms Design and release work instructions, process documentation, and in-process controls to ensure repeatable and scalable manufacturing. Continuous Improvement & Lean Manufacturing: Drive continuous improvement initiatives using Lean tools (e.g., value stream mapping, standard work, visual management). Conduct time and motion studies, line balancing, and workstation optimization to improve efficiency and reduce waste. Support tier-based escalation and visual factory systems to monitor and resolve Safety, Quality, Delivery, and Cost (SQDC) issues on the floor. Implement data-driven process controls to reduce variability and increase yield. Lead root cause investigations and corrective actions (CAPA) to address systemic production issues. New Product Introduction (NPI) & Client Integration: Act as the manufacturing lead for NPI, owning process development and validation deliverables throughout the product lifecycle. Collaborate with R&D, client engineering, and internal stakeholders to ensure design-for-manufacturability (DFM), smooth design transfer, and process readiness. Define and execute NPI activities such as PFMEA, pilot build support, validation plans, and readiness reviews. Serve as the technical point of contact for client engagements, audits, and feedback loops related to manufacturability and scalability. Documentation, Change Control & Compliance: Maintain controlled documentation including work instructions, BOMs, test protocols, and validation records in accordance with ISO 13485 and FDA 21 CFR 820. Initiate and process Engineering Change Orders (ECOs) and Document Change Orders (DCOs) to ensure technical documentation is up to date and reflects approved changes. Ensure robust configuration control across drawings, specifications, and revision history. Own or support Nonconformance Reports (NCRs) by conducting root cause analysis, implementing containment and corrective actions, and collaborating with Quality and Production. Participate in or lead Material Review Boards (MRBs) to disposition nonconforming material and drive resolution. Cross-Functional Collaboration: Work closely with Quality, Supply Chain, Planning, and Production teams to resolve issues, implement improvements, and meet customer and regulatory requirements. Translate client product requirements into manufacturable solutions and operational procedures. Represent manufacturing in client meetings, audits, and design reviews. Leadership & Mentorship: Provide technical mentorship to junior engineers and manufacturing support staff. Lead Kaizen events, RCCA investigations, and continuous improvement initiatives across departments. Contribute to the development and tracking of engineering and production metrics in alignment with SQDC performance indicators. Support tier-based daily management systems to ensure timely escalation, resolution, and communication of key operational issues. EDUCATION, EXPERIENCE, SKILLS AND ABILITIES REQUIRED: Education & Experience: Typically requires 2+ years of experience, and a mechanical, electrical or industrial engineering Bachelor’s degree from four-year College or university, or the equivalent combination of education, experience and training that provides the required knowledge, skills and abilities. Job Complexity: Works on problems of diverse scope and high complexity, often with incomplete or ambiguous information. Requires in-depth analysis and a strong understanding of manufacturing systems, regulatory constraints, and client expectations. Exercises sound judgment in selecting methods, techniques, and evaluation criteria to develop scalable and compliant solutions. Independently drives initiatives while building strong internal and external relationships across engineering, quality, production, and client teams. Knowledge, Skills & Abilities: Knowledge of manufacturing principles including Lean, Built-in Quality, 5S, single-piece flow, poka-yoke, throughput, utilization, and process capability. Skilled in PFMEA, control plans, process validation (IQ/OQ/PQ), and test method development. Experienced with root cause analysis (8D, 5 Whys, fishbone), CAPA, SPC, Gage R&R, and risk-based quality tools. Proficient in interpreting mechanical drawings, GD&T, electrical schematics, and BOMs. Familiar with mechanical and electromechanical components (motors, gears, sensors, adhesives, fasteners, fluidic systems, optics systems, and PCBAs). Understanding of fabrication and assembly methods including machining, molding, welding, and surface treatments. Knowledge of FDA 21 CFR 820, ISO 13485, and regulatory compliance practices (CE, UL). Experience with ECOs, DCOs, NCRs, MRB, and configuration control processes. Ability to support NPI from prototype through production and engage directly with clients on design transfer and manufacturability. Effective in cross-functional collaboration and tiered issue escalation aligned with SQDC (Safety, Quality, Delivery, Cost) performance metrics. Proficient in CAD (SolidWorks preferred), ERP/document control systems, and MS Office; experience with test automation or simulation tools is a plus. Strong communication, problem-solving, presentation, and mentorship skills. EFFORT REQUIRED: Physical Activities: This position primarily requires the ability to sit at a desk and work on a computer for extended periods of time, including frequent use of a keyboard and other standard office equipment for written and electronic communication. The role occasionally involves walking through production areas, standing during inspections or meetings, and lifting objects up to 25 pounds. Telephone communication may also be required intermittently. The work environment includes both office and manufacturing floor settings, with a typical noise level that is moderate. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job. TRAVEL: This position may require some travel for up to 10% of the time. This is an on-site position in San Diego with an annual salary range of $90,000 - $110, 000, based on experience and qualifications Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.