Quality Engineering Manager – Medical Device

Quality Engineering Manager – Medical Device

Quality Engineering Manager – Medical Device

Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Kaye/Bassman InternationalExperienced Biotech and Pharma and Medical Device Regulatory Affairs and 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 levelEmployment type

Employment type Full-timeJob function

Job function Quality Assurance, Engineering, and Project ManagementIndustries Medical Equipment ManufacturingReferrals increase your chances of interviewing at Kaye/Bassman International by 2xInferred from the description for this job

Medical insuranceVision insurance401(k)Paid maternity leavePaid paternity leaveGet notified when a new job is posted.Sign in to set job alerts for “Quality Engineering Manager” roles.

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