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SUMMARY The Quality Control (QC) Inspector II works in a timely manner to execute the required duties and responsibilities of this position. The Quality Control Inspector II position works with the Operations and the Quality Teams to promote quality management throughout the facility in order to ensure product quality levels are consistent with Company standards and customer expectations. The QC Inspector II is mindful of opportunities for continual improvement of manufacturing and inspection processes to increase quality, reduce waste, and improve efficiencies. The QC Inspector II is aware of regulatory requirements and reduces product liability by mitigating risk through quality management. ESSENTIAL DUTIES AND RESPONSIBILITIES Adhere to the Company’s Quality Management System to ensure compliance with applicable regulatory requirements. Inspect device components and finished devices following inspection instructions and established procedures. Inspect device components using manual and advanced video inspection equipment in the facility. Maintain and create new inspection procedures as required. Communicate inspection results to Quality Supervision and other team members as required. File quality documents and records and maintain quality files. Assist with process validation work to support manufacturing needs, if required. Assist new employees with understanding inspection processes, methodologies, and quality procedures. Perform special assignments as directed by supervision commensurate with experience. Perform other duties as assigned. 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 employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. SUPERVISORY RESPONSIBILITIES Direct Reports: Yes N/A QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Two to five years’ experience in an industrial manufacturing, quality manufacturing, or industrial medical device manufacturing environment required. Able to use manual inspection instruments including, but not limited to micrometer, calipers, optical comparators, toolmakers, etc. required. Able to read and understand blueprints. Able to locate and measure dimensions such as length, angle, arcs, radii, etc. Experience with computerized record-keeping (e.g., documents, drawings) preferred. Computer literacy with standard software applications. Excellent written and verbal communication skills. EDUCATION AND/OR EXPERIENCE High School diploma or equivalent preferred. Two years’ inspection experience required. CERTIFICATES, LICENSES, REGISTRATIONS None WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The manufacturing environment is an industrial setting dedicated to the production and assembly of medical devices that utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. This position's time is split between office and manufacturing environments. Occasionally, the Team Member in this position may be asked to work a split-shift for training and meeting purposes. PHYSICAL DEMANDS Analysis of Physical Demands N =Never, R = Rarely Less than 1 hour per week, O = Occasional 1% to 33% of time, F = Frequent 34% to 66% of time C = Constant over 66% of time Activity Frequency Activity Frequency Lifting/Carrying N R O F C Twisting/Turning N R O F C Under 10 lbs Reach over shoulder 11-20 lbs Reach over head 21-50 lb Reach outward 51-100 lbs Climb Over 100 lbs Crawl Pushing/Pulling N R O F C Kneel Under 10 lbs Squat 11-20 lbs Sit 21-50 lbs Walk-Normal Surfaces 51-100 lbs Walk-Uneven Surfaces Over 100 lbs Walk-Slippery Surfaces Other N R O F C Stand Keyboard/Ten Key Bend Fingering (fine dexterity) Driving N R O F C Handling (grasping, holding) Automatic Trans Repetitive Motion - Hands Standard Trans Repetitive Motion - Feet 2nd shift: Monday - Thursday 3:45 pm - 1:45 am
Hydranautics is a part of the Nitto Group of companies and a global leader in the field of integrated membrane solutions which includes reverse osmosis, nanofiltration, ultrafiltration and microfiltration for water, wastewater and process treatment and applications. Currently used on seven continents throughout the world for diverse applications such as seawater desalination, industrial high-purity water, surface water treatment, wastewater treatment and specialty process applications. Here at Hydranautics, we believe that diversity is key to our competitive advantage. All qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, marital status, domestic partner status or medical condition. We are proud to be a Drug-free, E-Verify and EEO employer. We are proud to offer a generous compensation and robust benefits package to include medical, dental, vision, life insurance plans, F.S.A. and H.S.A plans, Retirement plans (401k and ROTH), (12) Paid company holidays, generous PTO, tuition reimbursement and career development, Employee Assistance Plan, and more. This is an onsite position in our Oceanside, CA facility. Please Note: This is a 1st shift, 6:30am-3pm, Monday-Friday role. JOB SUMMARY: Under direct supervision, performs machine operator tasks as setting-up or shutting-down machines, prepares material for production loading and unloading on to machine or production equipment; maintains required level of output; monitors output by completing detailed quality inspections to ensure product meets customer requirements. Keeps accurate records and logs associated with production, measuring, quality, quantity, and any other necessary record-keeping activities. ESSENTIAL DUTIES and/or RESPONSIBILITIES: * Verifies gauges have current calibrated sticker prior to using hand tool to prevent damage to product. * Confirms trim measurement using calibrated hand tools such as ring gauges, trim gauges, etc. * Operates standard product trimming machine, including cleaning blade before using it. * Loads/unloads product from manufacturing transport equipment on to appropriate machine or production equipment for tasks. * Maintains daily, weekly, and monthly productivity goals set by production management, including clean-up, rework, core tube preparation or other production activities. * Documents product data information such as serial number, defects, rejects, scarp etc. on production logs, reports, or summaries as well as any other record keeping activities as it pertains to products throughout shift. * Follows all quality, safety and lean manufacturing policies, processes or procedures including sustaining workstation and area in cleanliness in accordance with 5S standards. * Informs Production Supervisor and/or Production Lead of increased pattern of defects in products. * Loads and unload elements to manufacturing equipment and back to the element rack within/between FRP Outerwrap, Trimming, Seal Carrier and Leak Test operations. * Ensures and verifies correct serial number present on all elements and recorded on appropriate documentation. * Assists in training new employees on standard operating manufacturing processes. * Maintains a level of productivity set by production management including rework. * Abides by all safety and quality standards and policies. * Maintains workstation resulting in a clean/safe environment using 5S lean manufacturing standards. * Other duties as assigned. MINIMUM EDUCATION and/or EXPERIENCE: * Six (6) months directly related experience manufacturing; high school diploma or GED; or an equivalent combination of education and experience. KNOWLEDGE, SKILLS and/or ABILITIES: * Understand and follow standard operating manufacturing processes and health, environmental and safety procedures. * Work independently and in a team fostering a cooperative spirit within a large and/or small team while maintaining flexibility to changing priorities. * Ability to set-up, operate and make minor adjustments to machines. * Basic to intermediate language skills, including verbal and written proficiency in English; ability to read work instructions in English. * Ability to work in a detailed-oriented atmosphere with accurate record-keeping, outstanding follow-through to meet production requirements and in a fast-paced manufacturing environment. * Recognize numbers and millimeters and perform basic mathematical calculations with the aid of a basic hand-held calculator. * Deal with standard and basic non-complex issues; basic problem-solving ability; carry out simple verbal work instructions. PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) * Must be able to stand frequently up to 8 hours a day. * Must be able to walk occasionally, up to 3 hours a day. * Ability to occasionally lift and carry items up to 50 pounds. * Ability to occasionally lift items overhead up to 25 pounds. * Ability to occasionally twist and bend at the waist, squat, and climb step stools occasionally up to 3 hours a day while prepping bundles. * Ability to push/pull racks, carts, and other manufacturing equipment occasionally up to 3 hours a day. * Ability to perform hand/wrist repetitions (up and down), by using calibrated tools, occasionally up to 3 hours a day. * Ability to reach occasionally up to 3 hours a day. * Ability to grasp objects with a force up to 50 pounds. * Gross hand manipulation of light-moderate strength is required to grab fiber bundles. * Fine hand manipulation of light-moderate strength is required to operate buttons on machine or computers. * Must be able to see/focus for close eye work (small figures) while conducting bubble testing, discriminate colors, and perceive depths. * Must be able to speak/hear verbal communications and respond to machine alarms/buzzers. * Subject to periodic exposures to varying temperatures, occasional exposure to noise levels above 85 decibels, gas/fumes/mists, and chemicals or hazardous materials while using personal protective equipment when required. * Must wear safety shoes in required areas. * Must be able to work extended hours per the demands of the business. * Participation in daily exercise activities is expected. Job Type: Full-time Pay: $20.00 per hour Expected hours: No less than 40 per week Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible spending account * Health insurance * Health savings account * Life insurance * On-the-job training * Paid time off * Parental leave * Prescription drug insurance * Referral program * Retirement plan * Tuition reimbursement * Vision insurance Work Location: In person
Hydranautics is a part of the Nitto Group of companies and a global leader in the field of integrated membrane solutions which includes reverse osmosis, nanofiltration, ultrafiltration and microfiltration for water, wastewater and process treatment and applications. Currently used on seven continents throughout the world for diverse applications such as seawater desalination, industrial high-purity water, surface water treatment, wastewater treatment and specialty process applications. Here at Hydranautics, we believe that diversity is key to our competitive advantage. All qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, marital status, domestic partner status or medical condition. We are proud to be a Drug-free, E-Verify and EEO employer. We are proud to offer a generous compensation and robust benefits package to include medical, dental, vision, life insurance plans, F.S.A. and H.S.A plans, Retirement plans (401k and ROTH), (12) Paid company holidays, generous PTO, tuition reimbursement and career development, Employee Assistance Plan, and more. This is an onsite position in our Oceanside, CA facility. Please Note: We have two openings. 1st shift, 6:30am-3pm, Monday-Friday and 3rd shift, 10:30pm-7am, Sunday-Thursday. JOB SUMMARY: Under direct supervision, perform machine operator tasks as setting-up or shutting-down machines, prepare material for production loading and unloading on to machine or production equipment; maintain required level of output; monitor output by completing detailed quality inspections to ensure product meets customer requirements. Keep accurate records and logs associated with production, measuring, quality, quantity, and any other necessary record-keeping activities. ESSENTIAL DUTIES and/or RESPONSIBILITIES: 1. Operates machine to seal the cage outerwrap to process separation products, conducting a visual inspection of elements for damage. 2. Seals cage outerwrap to feed spacer on the end seal glue lines. 3. Trims leaves manually using scissors eliminating flaps and exposing proper placement of serial number. 4. Some positions may verify glue ratio, including proper placing, accuracy, consistency, and diameter of glue lines in accordance to Manufacturing Standard Operating Procedures. 5. Loads/unloads product from manufacturing transport equipment on to appropriate machine or production equipment for tasks. 6. Maintains daily, weekly, and monthly productivity goals set by production management, including clean-up, rework, core tube preparation or other production activities. 7. Documents product data information such as serial number, defects, rejects, scrap etc. on production logs, reports, or summaries as well as any other record keeping activities as it pertains to products throughout shift. 8. Follows all quality, safety and lean manufacturing policies, processes or procedures including sustaining workstation and area in cleanliness in accordance with 5S standards. 9. Informs Production Supervisor and/or Production Lead of increased pattern of defects in products. 10. Other duties as assigned. MINIMUM EDUCATION and/or EXPERIENCE: 1. Six (6) months manufacturing experience; high school diploma or GED; or an equivalent combination of education and experience. KNOWLEDGE, SKILLS and/or ABILITIES: 1. Set-up, operate and make minor adjustments to machines. 2. Basic to intermediate language skills, including verbal and written proficiency in English; ability to read work instructions in English. 3. Work independently and foster a cooperative spirit within a large and/or small team while maintaining flexibility to changing priorities. PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) 1. Will be required to stand for the duration of the shift. As with most production positions, long periods of standing (app. 6 to 8 hours) and walking are necessary to run the assigned equipment. 2. Some lifting and material maneuvering is required to set up and during material change over. Average lifting weights may reach 20 to 30 lbs. Typical lifting techniques in the prep area are 2-person. The average times lifting is required is app. 2 to 3 times per shift (5-to-10-minute increments). 3. Repetitive light grasping is required to transfer prepped material (element packs) onto prepped membrane carts. 4. Typical pushing requirement is equivalent to approximately 20 lbs. Carts will need to be transferred to the Rolling area app. 6 times per shift. 5. Waist high lifting for membrane and overhead for brine spacer material is required. 6. Hand light grasping is required for handling membrane and brine spacer material. 7. Follows all quality and safety policies. 8. Maintains workstation and area cleanliness according to 5S standards. 9. Participation in daily exercise activities is expected. 10. Safety shoes must be worn. 11. Other Personal Protective equipment such as hearing protection may also be required depending on the position being performed. 12. Must be able to work extended hours per the demands of the business specifically for month-end closing. 4. Ability to work in a detailed-oriented atmosphere with accurate record-keeping, outstanding follow-through to meet production requirements and in a fast-paced manufacturing environment. 5. Recognize numbers and millimeters and perform basic mathematical calculations with the aid of a basic hand-held calculator. 6. Deal with standard and basic non-complex issues; basic problem-solving ability; carry out simple verbal work instructions. Job Type: Full-time Pay: $20.20 per hour Expected hours: No less than 40 per week Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible spending account * Health insurance * Health savings account * Life insurance * On-the-job training * Paid time off * Prescription drug insurance * Referral program * Retirement plan * Tuition reimbursement * Vision insurance Work Location: In person
Who are we: Magnaflow is a leading manufacturer and supplier based in Oceanside, CA of premium products to the automotive aftermarket industry such as catalytic converters, performance exhaust and replacement exhaust. Through the Camburg division in Huntington Beach, CA. Magnaflow also supplies race-inspired performance suspension products and vehicle uplifting services, Magnaflow is focused on future growth through both new business development and new product introduction. our websites are www.magnaflow.com and www.camburg.com. Salary Range: $84,000 to $100,100 USD Annually *Final agreed upon compensation will be based on a variety of factors including but not limited to an individual’s related experience, education, certifications, skills, and work location. What you will be doing: Plays a critical role in maintaining and improving the quality of processes and products to meet or exceed the highest levels of customer service. Supports manufacturing engineering in designing processes which meet ISO 9001:2015 standards and company quality guidelines. Continuous evaluation and improvement in the PPAP process for specific customers. Responsibilities: Assist in the definition of quality improvement factors through capability studies to ensure specified tolerances are within the process capabilities and are consistently being met. Implement methods to inspect, test and evaluate reliability and repeatability of manufacturing processes. This includes CPK studies. Prepare reports that demonstrate the performance of the manufacturing operations as compared to established quality standards. Maintains and publishes KPI and other related tracking reports to analyze quality trends with RMAs and Nonconforming issues and identify opportunities for improvements. Drive root cause analysis of issues and assist in the development of long-term solutions (Corrective Action / Preventive Action). Ensure Corrective and Preventive Actions are sustainable. Assist in driving cost of customer returns and Cost of Poor Quality (COPQ) down through root cause investigation and analysis. Establish new and maintain existing process failure mode and effect analysis, ongoing process control plans and process flow diagrams for all processes. Assist with conducting training on quality control, reliability and Continuous Improvement initiatives. Evaluates quality assurance equipment designed by others and maintains records of Gage R & R studies to be presented as needed for all levels of PSW for PPAP requests. Assists workers engaged in inspection and testing activities to ensure continuous control over materials and products. Assist in the approval of NPI production fixtures to implement Poka-yoke solutions where applicable. Initiate and implement programs aimed at improving the quality of operations and reducing the total cost of quality. Participates in and supports the maintenance and continuous improvement of the company Quality Management System (QMS). Maintain current calibration certificates for all customer provided (owned) tooling and fixtures that require calibration to comply with customer specifications. Requirements: Some studies in Mathematics, statistical analysis, Bachelor’s degree in engineering or related field from an accredited four year university, or equivalent experience. 2-5 years related work experience; or equivalent combination of education and experience. ISO 9001:2015 Time Management Project Management Statistical Analysis ASQ Certified Quality Engineer (CQE), preferred. Experience with Lean Manufacturing, Six Sigma certification preferred (Green or Black Belt). Experience working with ISO 9001 Quality Management Systems Requirements. ISO auditing experience is a plus. Able to read and understand mechanical drawings using ASME Y14.5 (Certificate of GD&T training preferred). Bending, Fabrication Assemble, Welding and Automated Processes experience is a plus. Proficient in MS Office, PowerPoint, Excel. Able to generate pareto charts and graphs. Bi-lingual (Spanish/English) preferred What’s in it for you? Competitive Salary PTO, Sick Pay, Birthday Holiday, Paid Holidays Medical, Dental, Vision 401k Matching (Up to 5%) Education assistance Company sponsored events Growing department and team
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role We are seeking a Glassware Operator II. This position is responsible for actively supporting the operations of the glassware department by collecting, cleaning, organizing and ordering glassware and supplies supporting the Manufacturing and Development departments. The Glassware Operator II also ensures cleaned and/or autoclaved glassware and equipment components are prepared as per manufacturing instructions or standard operating procedures and are available when required to meet the production schedule. General administrative activities include communication with the production leadership to understand the production schedule and communication with facilities for any equipment issues and coordination of preventative maintenance. This position will be located onsite in Carlsbad, CA. The Responsibilities Collects, cleans, stages and organizes glassware and supplies to support the operation of the manufacturing and development areas. Collects and removes glass receptacles from the labs and production areas. Dispositions and removes broken or damaged glassware. Coordinates and performs autoclave responsibilities. Determines glassware and supplies deficiencies and order all material within corporate financial planning structure Coordinates with facilities, preventative maintenance of equipment and repairs. Performs other duties as assigned. The Individual Required: High School Diploma or Equivalent General computer knowledge Good organizational skills Good verbal and written communication skills Good interpersonal skills Preferred 2-3 years’ experience in a glassware environment Previous experience handling biohazard material Knowledge of QSR’s and ISO 9001 The Key Working Relationships Internal Partners: Lab and Production Personnel, Manager, Facilities, Safety The Work Environment The work environment characteristics are representative of both a laboratory and glassware environment and may include the handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. The Physical Demands Position requires ability to lift up to 50 lbs. on a regular basis. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, regularly required to use hands to finger, handle, or feel and talk or hear. Frequently required to stand, walk, and sit. Occasionally required to reach, climb or balance. On a typical day, 90% of time is spent in a laboratory environment; 10% in an office environment in meetings or interacting with team members. May require significant domestic travel. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $42,000.00 - $55,000.00 annually. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Employment Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected] . #LI-HF1
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role We are seeking an Associate Operator role. Under close supervision, this position is responsible for a variety of assembly and non-assembly functions in support of manufacturing goals. This position will be on 2nd shift from 2:00 pm - 10:30 pm, located onsite in Carlsbad, CA. The Responsibilities Operates equipment used to manufacture products Checks and inspects products against departmental procedures Responsible for recognizing product or equipment problems that arise during the manufacturing process Maybe required to assist with the set-up and clean-up of manufacturing equipment Responsible for Lean Initiatives Carries out duties in compliance with established business policies Performs other duties & projects as assigned The Individual Required: 0 - 2 years of related experience Basic knowledge of regulations (FDA, ISO, OSHA, etc.) Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities Preferred High school diploma or equivalent Experience in medical device manufacturing MS Office and manufacturing systems The Key Working Relationships Internal Partners: Operators, mechanics, engineers and management The Work Environment The work environment characteristics are representative of a manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. Works on assignments that are routine in nature. The Physical Demands Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual lamination, manual cassette assembly, pouch inspection, etc.) up to 90% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $36,000.00 - $45,000.00 annually. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Employment Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected] . #LI-HF1
Sr. Production Team Lead, Lighteum Salary Range: $28-$32/hr At Medical Device Components, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancing the lives of patients worldwide by delivering innovative, high-quality medical components to the MedTech industry. Be a part of a team dedicated to playing a role in creating solutions that make a real impact. Your work will contribute to improving lives. We offer a comprehensive benefits package designed to support our associates' well-being. Our health and wellness benefits feature comprehensive medical, dental, and vision insurance. To promote financial security, we also provide a 401(k) plan with generous company contribution and match, flexible spending accounts, and life and disability insurance. Our paid time off policy is generous including PTO, sick leave, and paid holidays. Be a part of our team today! Sr. Production Team Lead, Lighteum $28-$32/hr JOB PURPOSE Supports the Site Leader in directing and coordinating the daily activities and development of production personnel engaged in the manufacturing and secondary operations of precision micromachined medical device components. PRINCIPAL ACCOUNTABILITIES/JOB DUTIES Lead a team of department personnel with support from the Site Manager. Directs the work assignments and is responsible for following up on the progress of these assignments throughout the shift. Coordinates with site leadership to develop standards and work instructions. Supports Site Manager in the planning and coordination of production activities to obtain optimum utilization of human resources, direct materials, and equipment. Responsible for upholding and enforcing. Has the authority to issue and enforce Company policies, procedures, and Management directives, and Lighteum Medical’s values. Supports the Site Manager in addressing employee concerns and facilitating effective resolution of workplace issues. Advises Management of new developments that may affect profit, schedule, costs, customer relations, and/or inter-departmental relations. Weekly review of attendance and appropriate approvals of time records for the department. Responsible for supporting performance feedback and annual reviews. Reviews quality issues, such as NCMRs, with assigned personnel, engineering, etc., and takes corrective action as required. Oversees the collection of production data and the analysis of that data and reports that data to the Site Manager. Ensure both self and team adheres to business EHS standards at all times, and that production does not override EHS requirements. Trains and brings awareness on EHS responsibilities to ensure a safe and compliant workplace Provides technical direction where applicable. Drives team to achieve site revenue goals. Other duties as assigned. QUALIFICATIONS/KNOWLEDGE/EXPERIENCE High school diploma or equivalent required A minimum of seven (7) years of experience in a manufacturing environment, preferably servicing the Medical Device Industry. A minimum of three (3) years of technical experience in a manufacturing environment, preferably servicing the Medical Device Industry. Associate’s degree in science or technical vocational school certification. Proficient in Microsoft Office, Word, and Excel. Ability to demonstrate strong technical troubleshooting skills with creative, effective solutions. Awareness of progressive management technologies such as Lean Manufacturing, JIT, MRP, and ERP. Ability to stand, sit, and walk frequently. PERSONAL SKILLS AND KEY COMPETENCIES Safety Awareness: Identifying and correcting conditions that affect employee safety; upholding safety standards. Building Collaborative Relationships: Identifying opportunities and taking action to build strategic relationships between one's areas, teams, departments, units, or organizations, including customers, to help achieve business goals. Decision Making: Obtaining information and identifying key issues and relationships relevant to achieving a long-range goal or vision; committing to a course of action to accomplish a long-range goal or vision after developing alternatives based on logical assumptions, facts, available resources, constraints, and organizational values. Initiating Action: Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive. Leading Teams: Using appropriate methods and interpersonal styles to develop, motivate, and guide the team to attain successful outcomes and business objectives. Medical Device Components is an equal opportunities employer and positively encourages applications from suitable qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership or maternity, religion or belief.
Intern - Engineering Pay: $21/hr At Medical Device Components, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancing the lives of patients worldwide by delivering innovative, high-quality medical components to the MedTech industry. Be a part of a team dedicated to playing a role in creating solutions that make a real impact. Your work will contribute to improving lives. We offer a comprehensive benefits package designed to support our associates' well-being. Our health and wellness benefits feature comprehensive medical, dental, and vision insurance. To promote financial security, we also provide a 401(k) plan with generous company contribution and match, flexible spending accounts, and life and disability insurance. Our paid time off policy is generous including PTO, sick leave, and paid holidays. Be a part of our team today! Intern - Engineering Pay: $21/hr JOB PURPOSE The Intern will provide technical support to Manufacturing Operations within a specific Value Stream. Assist in designing or improving equipment and machines to ensure efficiency, as well as assisting in planning or modifying production processes. This role requires the Intern to support the operations, which include the technical aspects of the processes. The Intern will balance their time between short and supporting large-scale projects. Short-scope projects will focus on process improvements within the Value Stream, while supporting large-scope projects that can span multiple Value Streams, functional departments, and involve more aspects of formal Project Management. PRINCIPAL ACCOUNTABILITIES/JOB DUTIES Coordinates experimentation, data collection, processing, and analysis to reach statistically significant conclusions. Assist with technical support to help manage change and troubleshoot problems within the Value Stream. Assist in the deployment of the Lean System, actively working on improvement projects. Collaborate with other functional areas to identify improvement opportunities within the Value Stream and will manage small scope projects to implement such improvements, focusing on safety, quality, delivery, and cost. Characterize, Optimize, and Validate equipment and processes based on statistical experimentation. Leads RCA efforts to improve upon safety and quality. Participate in local programs and initiatives to improve EHS performance. Work on basic engineering challenges containing a few variables with solutions usually known at the time of assignment. QUALIFICATIONS/KNOWLEDGE/EXPERIENCE Pursuing a Bachelor’s degree in Engineering or Science. Knowledge of applying Lean Manufacturing and Six Sigma. Have a basic understanding of manufacturing/transformation processes. Proficient in Office 365 and other software to support his/her work. The ability to interpret standard instructions furnished in written, oral, diagram, or schedule form. Ability to occasionally lift 10 – 20 pounds. PERSONAL SKILLS AND KEY COMPETENCIES Medical Device Components is an equal opportunities employer and positively encourages applications from suitable qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership or maternity, religion or belief.
Leading Biotechnology company has an immediate opening for a QA Associate. *SUMMARY:* The QA Associate I is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. The Associate I promotes a cGMP environment and collaborates with internal team members to ensure adherence to specifications, processes, and procedures. The Associate I performs documentation review and ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Understanding and execution of basic cGMP and GDP principles is required. ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED: * Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records. * QMS process support for change controls and quality investigations. * Performs AQL inspection of final filled product. * Performs area line clearance operations in support of manufacturing operations. * Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations. * Generate labels for cGMP use. * Reviews, approves, and reconciles labels for cGMP use. * Sterile gown qualified to support cGMP activities in sterile suites. * Assists in the review and data entry of Calibration and Preventative Maintenance records. * Assists in the review of equipment and facility related Change Control documentation. * Maintains equipment files and archives. * Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. * Embodies Company's cultural values and aligns daily actions with department goals and company culture. *EDUCATION AND EXPERIENCE:* * High School Diploma or equivalent required. Bachelor’s degree in a Life Sciences discipline preferred * Zero to two (0-2) years of relevant experience in documentation, QA, or equivalent. * Knowledge of cGMP regulations and good documentation practices preferred. * Experience with Computerized Maintenance Management Software (CMMS) preferred. * Demonstrated ability to follow detailed directions in a laboratory environment preferred. * Ability to work independently, within prescribed guidelines, and as a team member *While performing the duties the employee is:* * constantly required to sit, and to reach to use computers and other office equipment * constantly stand for extended periods of time, up to four (4) hours/time. * frequently required to lift up to 50 pounds * constantly required to view objects at close and distant ranges with hand and eye coordination * frequently required to communicate with others Job Type: Full-time Pay: $23.00 per hour Benefits: * Health insurance Work Location: In person
DEPARTMENT: ABLATIVES REPORTS TO: PRODUCTION SUPERVISOR FLSA STATUS: NON-EXEMPT EMPLOYMENT STATUS: FULL-TIME Position Summary: Responsible for performing all tasks involved in the fabrication of the company's ablatives and thermal structures. The position follows standard work methods and practices safe work habits to ensure production is as efficient and safe as possible. Essential Duties and Responsibilities: •Prep and maintain tools in accordance with specified guidelines and procedures •Accurately follow work instructions •Check completed products for conformance to specifications and for defects by checking them visually •Records information on appropriate production records, logs and other report forms •Performs re-work as required •Cleans and reseals tools using the appropriate release systems •Be aware of FOD & Tool control at all times •Continuously demonstrate 5S Application •Adheres to the highest practicable safety and housekeeping standards. •Repairs defective products rejected by inspection or test personnel •Required participation in internal training as needed to perform the duties assigned to this role •Other duties as assigned Requirements: Minimum Qualifications (Knowledge, Skills and Abilities) •U.S. Person status required do to export control •High School Diploma or GED preferred •1-2 years of manufacturing experience preferred •Composite experience highly preferred •Strong organizational skills •Strong attention to detail and craftsmanship •Must be able to verbally communicate, read and comprehend written and verbal instructions in English •Capable of doing simple mathematical calculations •Familiar with a variety of hand tools and measuring instruments • Ability to communicate effectively with coworkers and the management team • Must be well organized, flexible, and able to work in a fast-paced manufacturing environment • Must thrive in a team-oriented and deadline-driven environment • Familiarity and skill with interpreting technical drawings and blueprints •Ability to communicate effectively with co-workers and the management team Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made. While performing the duties of this Job, the employee is regularly required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. The employee may have to occasionally lift and/or move up to 50 pounds at times. While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee must regularly possess manual dexterity to put parts or pieces together quickly and accurately. The employee is frequently exposed to high, precarious places; fumes or airborne particles; outside weather conditions; extreme heat and risk of electrical shock. The noise level in the work environment is usually loud. Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.
Are you someone who catches the smallest details others might miss? Do you love working with people across different teams to make sure everything adds up just right? If so, we’d love to talk. We're looking for a QA Associate to join our team. This is a great opportunity for someone early in their quality career looking to dive deeper into the world of quality systems and manufacturing compliance. As a QA Associate, you’ll play a key role in keeping our processes compliant and our products safe. Your day-to-day focus will be on batch record review, making sure documentation is accurate, complete, and ready to move to the next phase. Here’s what that looks like: Reviewing batch records of raw material and finished goods to ensure completeness, compliance, and accuracy Following up with operations, R&D, and other cross-functional teams to support the resolution of discrepancies, non-conformances and deviations Ensuring all documentation aligns with cGMP (current Good Manufacturing Practices) Supporting QA investigations and change control processes Helping maintain quality records and documentation systems Who are you? You bring 1-2 years of experience within a quality assurance team and demonstrate a strong commitment to effective collaboration and communication. Your excellent organizational abilities enable you to thoroughly review documentation, ensuring compliance with industry standards and regulatory requirements. You take full ownership of your responsibilities and are dedicated to achieving accuracy in your work from the outset. Additionally, you possess familiarity with cGMP or regulated manufacturing environments. This is a full time, fully onsite position. SEKISUI offers a competitive compensation and benefits package The anticipated hourly wage for this position is $24-$29. This role may also qualify for annual incentives and/or comprehensive benefits. The actual base salary offered will depend on a variety of factors, including without limitation, the qualifications of the individual applicant for the position, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location of the position. ABOUT US: At SEKISUI Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level. As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions. SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities 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 notice from the Department of Labor.
Responsible for a safe and comfortable environment in accordance with established policies and procedures, for staff and patients throughout the facility. Operates cogeneration plant and support equipment, 12kv electrical distribution system, pneumatic air systems, HVAC equipment, and boiler and steam systems. Responsible for performance of preventive and repair maintenance on various types of electrical and mechanical equipment. Provides training and inservices for the department. Serves as a team member in the development and implementation of new programs for the department. Responsible for utilizing appropriate work practices commensurate with the environment of work to include working with neonates, pediatrics, adolescents, young adults, mature adults, older adults and psychiatric care patients. Speak and read English at a level that is sufficient to satisfactorily perform the essential functions of the position. Knowledge of standard office equipment (i.e., calculator, fax, photocopier) and personal computer and computer software skills (i.e., MS Windows, Excel, Access, Word, Powerpoint, internet, e-mail). Windows computer skills including proficient use of keyboarding, use of mouse or keys for functions such as selecting items, use of drop down menus, scroll bars, opening folders, copying and similar operations required upon employment or within the 1st two weeks of employment to perform the essential functions of the job. Performs other duties as assigned. Follows Palomar Health rules, policies, procedures, applicable laws and standards. Carries out the mission, vision, and quality commitment of Palomar Health. Job Requirements Minimum Education: High School Diploma and/or combination of education and experience Preferred Education: Specialized vocational training Minimum Experience: 4 - 5 years related plant operations Preferred Experience: 6 - 8 years related plant operations Required Certification: Not Applicable Preferred Certification: Not Applicable Required License: Valid Driver's License Preferred License: Not Applicable