Quality Engineering Manager – Medical Device
Quality Engineering Manager – Medical Device
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Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International
My client is a leading innovator in medical device technology, specializing in cutting-edge, laser-powered solutions that advance patient care. Their mission is to push the boundaries of what's possible in healthcare through groundbreaking innovation, precision engineering, and a deep commitment to improving clinical outcomes.
If you're passionate about making a real impact in the world of medical technology, this is your opportunity to join a purpose-driven team that's shaping the future of healthcare—one innovation at a time.
Position Summary: The Quality Engineering Manager will lead a team of quality engineers and specialists to ensure that all medical device products meet regulatory requirements, quality standards, and customer expectations.
Responsibilities:
* Provide manufacturing quality engineering leadership to manufacturing and sustaining engineering.
* Manage direct reports by providing direction, mentorship, and growth opportunities.
* Report on the Manufacturing and Quality KPIs.
* Conduct product design control activities for new and sustaining product development efforts.
* Support risk analysis activities, including design and process FMEA.
* Participate in the reliability/customer complaint team meetings.
* Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
* Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications for in-house / external manufacturing.
* Prepare for and participate in internal and external audits with notified bodies and customers.
* Perform other duties as assigned to support the advancement of the QMS and product manufacturing.
Experience/Qualifications:
* Bachelor’s degree in science, engineering, or other related technical discipline.
* 10+ years of experience in medical device quality engineering.
* Extensive experience in quality management within the medical device industry.
* Solid understanding of medical device ISO 13485, FDA 21 CFR 820.
* Familiar with MDR (EU) 2017/745/MDD, ISO 14971.
* Experience with intravascular catheters and/or electro-mechanical hardware.
* Medical device software experience is a plus.
* Experience with sterile products is preferred.
* Able to effectively manage workload and deliverables.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance, Engineering, and Project Management
* Industries
Medical Equipment Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
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