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GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: We are seeking a Manager, Compliance Engineering to lead compliance testing activities for a portfolio of innovative medical devices. This role is responsible for developing and executing compliance test strategies, managing product certification efforts, and ensuring products meet applicable safety, EMC, wireless, and regulatory requirements. As a key technical leader, you will work closely with Engineering, Quality, Regulatory Affairs, and external test laboratories to guide products from development through certification and commercialization. The ideal candidate combines strong technical expertise in medical device testing with the ability to lead teams, manage complex projects, and drive continuous improvement. The Manager, Compliance Engineering Drives Product Compliance Through Testing Excellence and is also responsible for; Lead compliance testing and certification activities for new products and product modifications. Develop compliance test strategies, plans, schedules, and resource requirements for product development programs. Oversee product testing related to safety, EMC, wireless, environmental, and other applicable regulatory requirements. Manage relationships with external test laboratories, certification bodies, and consultants, ensuring quality, cost, and schedule objectives are achieved. Review and approve test plans, protocols, reports, risk assessments, and certification documentation. Partner with Engineering teams to identify compliance risks early and drive effective testing and mitigation strategies. Support design reviews and risk management activities with a focus on product safety, performance, and regulatory compliance. Monitor changes in regulatory requirements and industry standards, assess impacts, and implement testing strategies to maintain compliance. Develop and improve compliance testing processes, tools, metrics, and best practices to increase efficiency and predictability. Lead, mentor, and develop a team of compliance engineers and test professionals. Manage departmental budgets and forecasting related to compliance testing, laboratory services, equipment, and resources. Ensure all activities are conducted in accordance with company policies and applicable quality, regulatory, privacy, and safety requirements. WHAT YOU’LL NEED: Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related technical discipline, or equivalent combination of education and applicable job experience. Advanced coursework, Master’s degree, or professional licensing in related field desirable. 5-8+ years of experience leading compliance testing, product certification, or regulatory engineering activities within the medical device industry. 5+ years of experience leading/supervising in a high volume, medical device, biotech, or pharmaceutical environment preferred. Strong knowledge of medical device safety and regulatory standards, including FDA QSR/QMSR, ISO 14971, and IEC 60601 series requirements. Experience managing external compliance testing laboratories and certification programs. Knowledge of EMC, electrical safety, wireless, and software/firmware compliance requirements for connected medical devices. Proven ability to lead technical teams and manage multiple compliance testing programs simultaneously. Experience with risk management, quality systems, GDP, and GMP requirements. Strong project management, communication, and stakeholder management skills. Demonstrated success driving process improvements and operational excellence within a testing or compliance organization. WHEN & WHERE YOU’LL WORK: Hybrid: This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work. This position is expected to be in office 3+ days per week but may vary depending on business demands. COMPENSATION & BENEFITS: The starting base pay range for this position is $141,800.00 - $177,300.00 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package. Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem’s benefits here! YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders. SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. WHY YOU’LL LOVE WORKING HERE: At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers. BE YOU, WITH US! We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications. Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow. #LI-Hybrid #LI-DW1
Artificial Greenery business is looking for a Welder/Fabricator. This position is Permanent Full-time 32-40 hours per week. Usually, Monday - Friday, 7am – 3:30pm, with OT as needed. Started in 2021, Unreal Designs is proud to offer custom designs with artificial greenery for purchase and standard options for event rental. In addition, we offer custom fabrication for special projects. We are looking for an experienced welder/fabricator to join our team full time. Please take a look below at some previously built and installed projects. Requirements: * The welder/fabricator utilizes MIG to fabricate an array of structural pieces. * All Welding is on site. * Ability to use hand tools and power tools. * Reliable. Should be able to lift 40 lbs. * Organized and detail oriented. * Maintain a safe, clean and organized work area. * Reading and comprehending shop drawings. * Ability to be self-sufficient to work productively alone or in a group setting. * A pre-employment drug test is required. We offer: * Great working environment * Competitive Wages * Collaborative Team * Somewhat flexible schedule if needed * Potential Travel on Installations Pay is dependent on work experience. Please email us with resume today to set up an interview. Job Type: Full-time Pay: $24.00 - $27.00 per hour Experience: * welding: 1 year (Required) Ability to Commute: * San Marcos, CA 92078 (Required) Work Location: In person
MACHINIST CNC LATHE OPERATOR Must have knowledge of HAAS controls and must have machining experience. Pay is based on experience. Full time 4/ 10 hour days Job Type: Full-time Pay: $22.00 - $23.00 per hour Benefits: * Health insurance Application Question(s): * Have you worked as a machinist before? How much experience do you have as a machinist? Experience: * HAAS controls and CNC/Lathe machining : 3 years (Preferred) Work Location: In person
*CNC Programmer / Setup Machinist — San Diego Part-Time / Full-Time* *$30+/Hr. starting — higher pay available based on experience and demonstrated ability.* We are seeking an experienced CNC Programmer / Setup Machinist with a minimum of 4 years of CNC experience and strong programming / setup skills. This is not simply an operator position. The ideal candidate can independently program, set up, prove out, troubleshoot, and manufacture precision components from engineering drawings. Experienced with Surfcam, Mastercam, Fusion 360 ~FADAL MILL FANUC 88 Controller ~HAAS Mills ~(Haas lathe CNC Programing / Setup expereince = added value) ~Able to work independently with occasional supervision and communication with owner. ~Mandatory background check Note: We are not working with external recruiters or staffing agencies. Please do not contact us regarding this posting. Only direct applicants will be considered. This is professional, firm, and reduces recruiter outreach without hurting legitimate applicants. Pay: $28.00 - $32.00 per hour Benefits: * 401(k) matching * Health insurance Application Question(s): * How many years have you worked as a CNC programmer and setup machinist? * What was your longest position with one employer, and how long were you there? * How many years have you used Mastercam, and how would you rate your ability from 1–10? * Can you independently take a job from drawing to finished part — including programming, tooling selection, setup, offsets, prove-out, and first-piece inspection? * This is a full-time, on-site position in San Diego. Do you expect San Diego to remain your work location for the foreseeable future? * Because our company performs government and sensitive customer work, employment is contingent upon completing all applicable background, security, and customer-access requirements after a conditional offer, consistent with applicable law. Are you comfortable proceeding under those requirements? * If selected, when could you realistically start? * What would be the ideal number of hours per week you would like to work? Education: * High school or equivalent (Required) Work Location: In person
Job Title : NC/CNC Programmer CUM Turning Operator Location: San Diego , CA (Onsite) Job type : Fulltime / Contract *Job Description:* Candidate should possess strong experience in Siemens NX CAM programming and shop-floor machine prove-out activities. Must be capable of generating and validating CNC programs, conducting simulation and collision checks, performing first-time prove-out on CNC machines, troubleshooting machining issues, and optimizing programs for aerospace manufacturing applications. ironment! Pay: $110,000.00 - $115,000.00 per year Benefits: * 401(k) * Dental insurance * Health insurance * Paid time off * Relocation assistance * Vision insurance Work Location: In person
The position is responsible for validation activities covering analytical methods, cleaning, production processes, equipment qualification, facilities/utilities qualification, and raw materials qualification. The role also includes generating and maintaining process FMEA, performing risk assessments for process-related non-conformances and planned deviations, supporting regulatory submissions, writing master validation plans, protocols, and reports, supporting equipment and facilities change controls, and performing validation impact assessments for change orders Responsibilities Provide Quality leadership to new product development teams in validation, design transfer, risk management, and specification development. Author master validation plans and reports. Author and execute validation protocols and reports for analytical methods, equipment, facilities/utilities, raw materials, process, and cleaning. Review the quality, validation impact, and completeness of document change order requests and equipment or facilities change controls. Determine validation strategy using an acceptable risk-based approach. Lead cross-functional teams to write PFMEAs under limited supervision. Perform process risk assessments for Non-Conformance Events and planned deviations. Maintain validation records and support cross-functional teams during New Product Introduction and Sustaining projects. Review regulatory submissions and notifications under limited supervision. Propose improvement projects using supporting data and flowcharts. Assist in updating departmental procedures and controlled documents. Evaluate specifications for new or modified process designs under limited supervision. Lead department and cross-department projects, determine QE deliverables, and help create project timelines. Participate in process design reviews, department process improvements, and department metrics reporting. Assist Quality Engineering management in Material Review Board and Production Response Team meetings. Provide management with status updates and escalate issues in a timely manner. Train new employees. Knowledge Bachelor’s degree in Science or Engineering is required. Working knowledge of CDRH, CBER, and ISO regulations, including 21 CFR Part 820, ISO 13485, and ISO 14971, is required. Working knowledge of 21 CFR Part 11 is required. Must follow all applicable FDA regulations and ISO requirements. Understanding of statistics, SPC, and acceptance sampling is required. Skills Proficient in validation methods and evaluation criteria. Experience with process validation, analytical method validation, cleaning validation, facility/utility qualification, and equipment qualification. Experience with change control processes and documentation requirements. Experience with electronic document management systems. Experience with risk analysis and PFMEA. Behavior Demonstrate Quality leadership in cross-functional and new product development settings. Work under limited supervision when leading PFMEAs, reviewing regulatory submissions, evaluating specifications, and leading department or cross-department projects. Support collaboration across teams during NPI and Sustaining projects. Communicate progress to management and escalate issues in a timely manner. Contribute to continuous improvement through departmental process improvement goals, improvement projects, and metrics support. Experience Requires 2+ years of experience in a diagnostic, medical device, biotech, or pharmaceutical company. Experience should include validation activities, change control, electronic document management systems, risk analysis, and PFMEA. Why join Hologic? We are committed to making Hologic the destination for top talent. 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. The annualized base salary range for this role is $79,700 - $124,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. 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 Manufacturing Total Quality Analyst supports and maintains the Quality Management System (QMS) to ensure compliance with company standards, customer requirements, and regulatory guidelines. This role is responsible for enforcing quality system requirements across manufacturing operations, holding processes, documentation, and production activities accountable to established standards. By actively monitoring compliance and addressing gaps on the production floor, this position helps prevent nonconformances and safeguard product quality and customer satisfaction. *KEY RESPONSIBILITIES* * Champion and uphold the company's values, mission, and quality policy in all activities. * Adhere to company policies, procedures, and internal control standards. * Ensure compliance with all applicable Quality Management System (QMS) requirements, including ISO 9001 and AS9100 as applicable to this role. * Prepares and manages document control and quality system documentation, including trend data review, inspection procedures, work instructions or other applicable quality management requirements. * Collects, analyzes, and reports quality data to identify trends and opportunities for process improvement. * Establish control plans as part of product realization and process improvements. * Lead root cause analysis and corrective/preventive action (CAPA) investigations for internal nonconformances, customer complaints and returned material. * Monitors customer and employee feedback to evaluate the effectiveness of manufacturing-related business systems and processes * Conduct internal audits and support external customer and third-party audits, addressing findings and driving closure of corrective actions. * Partner cross-functionally with Engineering, Production, and Supply Chain teams to resolve quality issues, implement corrective actions, and verify effectiveness of process changes. *EDUCATION* * Bachelor's degree in Business, Quality, Mechanical or Industrial Engineering required. * Prior experience in an AS9100 or ISO9001 manufacturing environment preferred. * Minimum of 2-4 years of experience in a quality related role, preferably in the biomedical, automotive or aerospace industry required. *SKILLS & QUALIFICATIONS* * Strong verbal and written communication skills. * Ability to independently organize and prioritize multiple tasks and duties. * Proficient with Microsoft Office and/or ERP/production software. Propel experience a plus. * Strong attention to detail and commitment to quality. * Strong analytical and problem-solving skills. * Working knowledge of quality system requirements under ISO 9001 and AS9100 as applicable to this role. * Certified auditor experience is a plus. * Preferred bilingualism in Spanish and/or Vietnamese. *TRAINING & COMPETENCY REQUIREMENTS* * Complete new-hire orientation and role-specific on-the-job training prior to performing unsupervised work. * Complete Quality Management System (QMS) training applicable to this role, including quality policy awareness and the consequences of nonconformance to product or process requirements. * Complete safety training applicable to this role. * Maintain competency through periodic refresher or retraining as required by department procedures and applicable regulatory requirements. *WORK ENVIRONMENT* * Office setting. Controlled-temperature environment. * Manufacturing floor environment. Exposure to moderate noise levels typical of a production floor. * Occasional exposure to dust, fumes, or chemicals typical of a plastics manufacturing environment. *PHYSICAL REQUIREMENTS* * Prolonged periods sitting at a desk and working on a computer. * Prolonged periods standing or walking on the production floor. * Mobility to navigate the production floor to conduct inspections. * Use of personal protective equipment (PPE) such as safety glasses while on production floor. *EXPECTED HOURS OF WORK* * This is a full-time salaried position, required to work Monday through Friday. Occasional weekend availability may be required based on business needs. *TRAVEL* * Up to 20% international travel required (Mexico). * Travel may be required for training, customer visits, or supplier audits as business needs dictate. Pay: $82,000.00 - $103,000.00 per year Benefits: * 401(k) matching * Dental insurance * Health insurance * Paid time off * Vision insurance Work Location: In person
The Manufacturing Total Quality Analyst supports and maintains the Quality Management System (QMS) to ensure compliance with company standards, customer requirements, and regulatory guidelines. This role is responsible for enforcing quality system requirements across manufacturing operations, holding processes, documentation, and production activities accountable to established standards. By actively monitoring compliance and addressing gaps on the production floor, this position helps prevent nonconformances and safeguard product quality and customer satisfaction. KEY RESPONSIBILITIES • Champion and uphold the company's values, mission, and quality policy in all activities. • Adhere to company policies, procedures, and internal control standards. • Ensure compliance with all applicable Quality Management System (QMS) requirements, including ISO 9001 and AS9100 as applicable to this role. • Prepares and manages document control and quality system documentation, including trend data review, inspection procedures, work instructions or other applicable quality management requirements. • Collects, analyzes, and reports quality data to identify trends and opportunities for process improvement. • Establish control plans as part of product realization and process improvements. • Lead root cause analysis and corrective/preventive action (CAPA) investigations for internal nonconformances, customer complaints and returned material. • Monitors customer and employee feedback to evaluate the effectiveness of manufacturing-related business systems and processes • Conduct internal audits and support external customer and third-party audits, addressing findings and driving closure of corrective actions. • Partner cross-functionally with Engineering, Production, and Supply Chain teams to resolve quality issues, implement corrective actions, and verify effectiveness of process changes. EDUCATION • Bachelor's degree in Business, Quality, Mechanical or Industrial Engineering required. • Prior experience in an AS9100 or ISO9001 manufacturing environment preferred. • Minimum of 2-4 years of experience in a quality related role, preferably in the biomedical, automotive or aerospace industry required. SKILLS & QUALIFICATIONS • Strong verbal and written communication skills. • Ability to independently organize and prioritize multiple tasks and duties. • Proficient with Microsoft Office and/or ERP/production software. Propel experience a plus. • Strong attention to detail and commitment to quality. • Strong analytical and problem-solving skills. • Working knowledge of quality system requirements under ISO 9001 and AS9100 as applicable to this role. • Certified auditor experience is a plus. • Preferred bilingualism in Spanish and/or Vietnamese. TRAINING & COMPETENCY REQUIREMENTS • Complete new-hire orientation and role-specific on-the-job training prior to performing unsupervised work. • Complete Quality Management System (QMS) training applicable to this role, including quality policy awareness and the consequences of nonconformance to product or process requirements. • Complete safety training applicable to this role. • Maintain competency through periodic refresher or retraining as required by department procedures and applicable regulatory requirements. WORK ENVIRONMENT • Office setting. Controlled-temperature environment. • Manufacturing floor environment. Exposure to moderate noise levels typical of a production floor. • Occasional exposure to dust, fumes, or chemicals typical of a plastics manufacturing environment. PHYSICAL REQUIREMENTS • Prolonged periods sitting at a desk and working on a computer. • Prolonged periods standing or walking on the production floor. • Mobility to navigate the production floor to conduct inspections. • Use of personal protective equipment (PPE) such as safety glasses while on production floor. EXPECTED HOURS OF WORK • This is a full-time salaried position, required to work Monday through Friday. Occasional weekend availability may be required based on business needs. TRAVEL • Up to 20% international travel required (Mexico). • Travel may be required for training, customer visits, or supplier audits as business needs dictate.
Overview: Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger. Primarily responsible for developing technical solutions and executing Lightspeed projects for medical device customers using Resonetics Advanced Technology. Collaborate with a small local Lightspeed team and with Lightspeed members from other sites to complete prototype projects and contribute on programs moving through the PReP process towards production. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you. Responsibilities: Define, plan, and execute Lightspeed projects per quoted conditions with innovation and urgency, ensuring product quality meets or exceeds technology specific workmanship standards Understanding of parameters and variables on Resonetics technology that effect process outputs Able to independently develop and troubleshoot workstation parameters to produce acceptable Lightspeed product using Resonetics Technology Take ownership and responsibility of assigned tasks and quality of deliverables, working across several departments as required Strong productivity and independence, ability to work under minimal supervision, continuously seeks out additional responsibilities Read and interpret print specifications on Lightspeed projects, ensure all required visual and geometric measurements are taken and documented per Quality Systems requirements Participate in quoting process as assigned and Generate quotes for customers Document process parameters and project details for each Lightspeed project accurately per Resonetics Quality Systems requirements Able to write basic programs to measure Lightspeed product using computer controlled metrology equipment, experience with Test Method Validations Communicate effectively and present technical content on internal & external calls and email conversations Proactively communicate with the customer on issues with a recovery plan, status, and results of an order with support from your manager Take ownership of data & metrics for responsibilities as assigned, ensuring data is accurately presented in Resonetics digital systems Works effectively on multiple projects at once, organizes and balances tasks with structure and purpose. Seeks continuous self-improvement, open and willing to accept constructive criticism Lead and take responsibility for sections of the PReP process, moving a project from Lightspeed to Production Participate in Advanced Technology Group activities and deliverables as requested Mentor and guide Lightspeed Technicians and Associate Engineers, and Applications Development Engineers Ability to adapt quickly and positively to changing priorities and processes Support site overall goals per Site Director, contributing to Production and Lightspeed programs as required Other duties as assigned Required Qualifications: Education and Experience Bachelor of Science degree in an engineering / science or equivalent experience Ability to read and understand engineering drawings per GD&T system Ability to generate drawings and models with 2D & 3D software using GD&T Fluent in Microsoft Office: MS Teams, Excel, PowerPoint, Outlook, SharePoint... etc. Demonstrated execution and experience with the following: TMV / GRR, Process Capability, Attribute vs. Variable Data in Validation, OQs/PQs, Engineering Study / DOE Experience using computer-controlled measurement systems to create and troubleshoot programs and inspection methods to measure Lightspeed product Soft Skills Ability to communicate on a technical level and non-technical level to peers in a respectful & professional manner Ability to present and convey complex engineering ideas to internal and external customers Strong time management and organizational skills, sensitive to the use of other people's time Strong problem-solving skills Preferred Qualifications: Experience with high precision manufacturing equipment (Laser Systems, CNC Machines, Grinding Machines, Tube Drawing Machines... etc.) Experienced in applying software used on high precision manufacturing equipment (G-code, C++, VBA, Various Equipment Specific GUIs… etc.) Familiarity with ISO certified Quality Systems in medical device manufacturing Basic understanding of materials science and materials properties, especially for common medical device materials (Nitinol, Stainless Steels, Titanium & othermetals, Medical Polymers and Ceramics) Experience in a medical device manufacturing environment Experience designing and manufacturing tooling or fixturing for various applications Physical Demands: Standing and walking for short periods of time Ability to use a microscope, including manipulating small objects under a microscope Compensation: The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65,000 –$102,000. Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This position is responsible for 8 sites globally, > 130 team members, and Quality teams performing critical Quality operational functions. This position works with a matrix of leaders and peers within and across divisions to provide Quality oversight, support, and consulting to our internal and external partners and customers. This is a complex role and will require travel (up to 30%) and interface with external customers and commercial teams to support divisional growth. This role will lead the GSD Quality organization from a tactical and strategic perspective and is responsible for driving the overall culture of personal quality in conjunction with the other organizational leaders. This role reports direct to the Vice President, Quality and Regulatory Affairs, Life Sciences Group with a matrixed reporting line to the President of the Genetic Sciences Division. Responsibilities: Member of the GSD Leadership Team; responsible for Quality strategy and implementation across operations sites and product lifecycle management. Leads the global Quality functions across GSD manufacturing operations network and responsible for consistent deployment and vigilance to Quality Management System (QMS) requirements and compliance to applicable regulations and standards, including CFR 820 -QSR, ISO13485, MDSAP. Advises business President and GSD leadership team on product quality matters, QMS customer focus, regulatory strategies for emerging markets/new product and technology introductions Drives quality plans to improve product fit for purpose, customer experience, and tools/technologies supporting manufacturing advances. Direct Responsibilities for 8 Site Based Quality Organizations, globally. Indirect Product Responsibilities across 3 sites, globally. Contributes to the Global GSD strategy, development, and execution of Quality Management Creates, enhances, and sustains compliance systems for registered medical devices Member of the LSG Quality & Regulatory Affairs Leadership Team and functions to champion and partner global QRA strategies and initiatives. Supports the Commercial Business, driving revenue as a critical business partner. Participates in cross functional team projects (R&D, Mfg, Vendors, etc) to support New Product launches. Manages matrix Peer relationships to ensure compliance of the network. Works across multiple Divisions, product lines and types of manufacturing processes seamlessly. Solves problems in complicated situations using analytical skills, creativity, and judgment Communicates internally to senior leaders and to diverse audiences. Provides training, mentors, and coaches team members and peers. Supports complex, cross-functional quality activities in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software). Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements. Addresses Emerging Regulations and compliance to written standards (e.g. ISO, QMSR), providing additional information for the site to ensure consistent application of quality processes. Ensures overall program and product quality improvement by guiding Peer groups in continuous process improvement implementing preventative actions and reviewing lessons learned. Minimum Qualifications: Bachelor’s degree in Science or Engineering Disciplines. 10 years experience within the Medical Device Industry supporting Research Use only and Regulated Products. Expert knowledge of Quality Management Systems and oversight from a IVD/Medical Device or Pharmaceutical perspective. Regulations and quality standards ((e.g., 21 CFR Part 820, ISO 13485, 9001, MDSAP, ICH), Quality Risk Management tools e.g. FMEA, Risk Analysis, RCA, Global IT Systems e.g. TrackWise, AGILE, E1/SAP, LIMS Multi-site Quality Operations experience Demonstrated proficiency in leading quality strategy, quality planning resulting in QMS metrics improvement and sustained regulatory compliance. Training in Lean Sigma/Six Sigma processes. Preferred Qualifications: Support of Medical Device or Pharmaceutical New Product Introductions Experience with establishing and maintaining a QMS supporting both RUO and Regulated products. Operational and strategic Leadership Strong proficiency in driving a culture of Quality Quality Engineering and Improvement Compensation and Benefits The salary range estimated for this position based in California is $210,200.00–$280,200.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Join our dynamic manufacturing engineering team at the San Diego Innovation Center of Excellence, where we lead development, scale up, and transfer of products, manufacturing processes, and equipment into operations, with a primary focus on advancing Dexcom Sensor technology. Responsibilities include providing day-to-day technical support for pilot plant processes and products at our San Diego site, build readiness evaluations, and procedural updates. Where you come in: Perform routine inspections of equipment and production areas and report any faults or issues to senior technicians, engineering or supervisors. Work with more experienced technicians and engineers on process improvements. Perform routine fault detection and SPC monitoring, routine verifications, inspections, and equipment setups. Diagnose process-related problems and implement corrective actions. Collaborate with engineering teams to help implement process improvements and test new products. Can conduct out of tolerance and calibration, and other equipment related preliminary investigations (LCIs, OOTs etc.) Assist in creating and revising standard operating procedures and other technical documentation. Solve complex problems: Troubleshoot and resolve highly complex machine and process issues. Optimize processes: Lead continuous improvement initiatives, applying methodologies like Lean Six Sigma. Conduct root cause analysis: Perform detailed root cause analysis for quality issues and incidents (SPSe). What makes you successful: Experience in a manufacturing environment Knowledge of Lean manufacturing principles Strong problem-solving and analytical skills SPC understanding Able to extract pictures and interpret failure modes by visual checks Ability to work independently and as part of a team Excellent communication and interpersonal skills Technical certification or coursework related to manufacturing processes Proficiency in using manufacturing software and tools Strong attention to detail and organizational skills High school diploma or equivalent/ associates degree or specialized training Associate degree in a technical field or equivalent experience Understanding of manufacturing processes and equipment Basic mechanical and electrical skills Ability to read and interpret technical drawings and schematics Experience with PLCs and automation systems Willingness to work flexible hours, including evenings and weekends Good physical condition and the ability to lift heavy objects Basic computer skills, including proficiency with Microsoft Office applications Commitment to safety and quality standards Ability to work in a fast-paced and changing environment What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected]. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. Salary: $24.90 - $37.30 #DexcomUS
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Develops, modifies, documents and directs the implementation and evaluation of quality assurance programs and systems on one or more mid-size to large projects. Provides expertise and guidance in interpreting quality standards and government regulations. Collaborates with engineering and manufacturing to ensure quality standards are in place. Works on moderately complex and diverse problems where analysis of situations or data requires in-depth evaluation of various factors. DUTIES AND RESPONSBILTIES: Identifies and recommends design or manufacturing changes and enhancements. Determines technical objectives for quality assurance as well as approaches to completing projects. Creates or recommends design, dimensional or manufacturing process changes to improve products and reduce costs. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Participates in functional testing and/or inspection of equipment and systems. Audits quality systems for deficiency identification and correction. Implements solutions to complex problems occurring internally and at vendor facilities. May prepare statistical analysis reports, specifications and other technical documents. Interprets and adapts quality standards and government regulations. Acts as company contact with suppliers, customers and regulatory personnel to resolve quality issues. Delivers technical presentations. Provides project direction to other staff members. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a bachelor's or master's degree in engineering or related discipline and six or more years of related experience with a bachelor's degree or four or more years with a master's degree. May substitute equivalent experience in lieu of education Must be able to apply a detailed understanding of inspection methods and have strong knowledge of computer operations and applications. Must have a strong knowledge of concepts, techniques, and methods in a particular field of specialization. Must have the analytical ability required to develop creative solutions to complex quality issues and the skills required to present those solutions to internal and external contacts. Must be detail-oriented to accurately prepare statistical reports and technical documents in support of company objectives. Must have strong leadership skills to direct staff members and ensure project costs and schedules are maintained while representing the organization on technical quality assurance issues. Able to deliver effective technical presentations and work extended hours as required. Ability to obtain and maintain DoD Security Clearance is required. Job Category Quality Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Salary Pay Range Low 89,180 Pay Range High 155,825 Travel Percentage Required 25% - 50% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? Desired Clearance Level Secret Search Jobs at | General Atomics and Affiliated Companies