Design Quality Engineer
3 weeks ago
Design Quality Engineer at Katalyst CRO Responsibilities Lead and support design verification and validation activities, including test method development and execution. Perform sample size selection and statistical data analysis to support design decisions and risk assessments. Conduct process capability studies and support design transfer to manufacturing. Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards. Collaborate with cross‑functional teams including R&D, Regulatory, and Manufacturing. Review and approve design documentation including Design History Files (DHF), risk management files and test protocols. Provide technical guidance and mentorship to junior QEs offshore. Support CAPA investigations related to design issues and contribute to continuous improvement initiatives. Qualifications Certified Quality Engineer (CQE) or equivalent certification. Experience with software tools such as Minitab, JMP, or similar statistical analysis platforms. Familiarity with risk management standards (ISO 14971) and usability engineering (IEC 62366). Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820). Seniority Level Associate Employment Type Contract Job Function Quality Assurance Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
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Design Quality Engineer
15 hours ago
Franklin Lakes, United States Katalyst Healthcares and Life Sciences Full timeRoles & Responsibilities:7 years of experience in medical device industryLead and support design verification and validation activities, including test method development and execution.Perform sample size selection and statistical data analysis to support design decisions and risk assessments.Conduct process capability studies and support design transfer to...
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Quality Engineer
3 weeks ago
Franklin Lakes, United States Katalyst CRO Full timeJob Responsibilities and Qualifications Lead and support design verification and validation activities, including test method development and execution. Perform sample size selection and statistical data analysis to support design decisions and risk assessments. Conduct process capability studies and support design transfer to manufacturing. Ensure...
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Quality Engineer
15 hours ago
Franklin Lakes, United States Katalyst Healthcares and Life Sciences Full timeRoles & Responsibilities:Lead and support design verification and validation activities, including test method development and execution.Perform sample size selection and statistical data analysis to support design decisions and risk assessments.Conduct process capability studies and support design transfer to manufacturing.Ensure compliance with FDA, ISO...
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Quality Engineer III
3 weeks ago
Franklin Lakes, United States Katalyst CRO Full timeThe Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality...
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Quality Engineer III
15 hours ago
Franklin Lakes, United States Katalyst Healthcares and Life Sciences Full timeJob Description:The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet...
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QUALITY ENGINEER
3 weeks ago
Franklin Lakes, United States Integrated Resources Inc. Full timeIRI believes in commitment, integrity, and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with decades of industry experience. We deliver strategic workforce solutions that help manage talent and business more efficiently. Since 1996, IRI has attracted and retained experts in our fields, enabling us to expand into new...
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Senior Quality Engineer
3 weeks ago
Franklin Lakes, United States Becton, Dickinson and Company Full timeJob Description SummaryThe Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure...
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EU MDR Quality Engineer
3 weeks ago
Franklin Lakes, United States MillenniumSoft Inc Full timePosition: EU MDR Quality Engineer - Onsite Location: Franklin Lakes, NJ Duration: 12 Months Total Hours/week: 40.00 Shift: 1st Shift Client: Medical Devices Company Job Category: Engineering/Technical Level of Experience: Mid-Level Employment Type: Contract on W2 (US Citizens, Green Card Holders, EAD or CPT holders) Hybrid: 4 days a week in office Travel:...
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Quality Engineer
3 weeks ago
Franklin Lakes, United States MillenniumSoft Inc Full timeQuality Engineer - Onsite (Urgent Need) – MillenniumSoft Inc Level of Experience: Mid-Level Employment Type: Contract on W2 (US Citizens, Green Card Holders, EAD, OPT, CPT) Work Arrangement: Hybrid, 4 days per week in office Location: Franklin Lakes, NJ Duration: 12 months Total Hours/week: 40 Shift: 1st Industry: Medical Devices Company Travel: Domestic,...
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Quality Engineer
3 weeks ago
Franklin Lakes, United States Integrated Resources Inc. Full timeA Few Words About Us Integrated Resources, Inc. is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We...