About this role
Supervise and improve quality engineering activities for medical device manufacturing, ensuring regulatory compliance and product quality. Lead investigations, audits, and corrective/preventive actions while using statistical analysis to identify and mitigate quality risks.
Key Responsibilities
- Ensure GMP (21 CFR 820) and ISO 13485 compliance
- Lead root cause analysis and CAPA
- Use statistical tools (sampling plans, control charts, DOE, ANOVA) for process monitoring
- Perform and support internal quality audits and supplier oversight
- Develop technical documentation and support CE marking activities
Technical Overview
Applies GMP (21 CFR 820) and ISO 13485 quality system requirements with strong design control and supplier/contract manufacturing oversight. Uses statistical methods (sampling plans, control charts, Design of Experiments (DOE), ANOVA) alongside data mining and trend analysis, and supports internal quality audits and CE marking documentation.
Ideal Candidate
The ideal candidate is an experienced quality engineering supervisor in medical device manufacturing with strong knowledge of GMP (21 CFR 820) and ISO 13485. They can run internal quality audits, lead CAPA and root cause analysis, and apply statistical tools such as sampling plans, control charts, Design of Experiments (DOE), and ANOVA. They are also comfortable working with contract manufacturers/suppliers and supporting CE marking technical documentation.
Must-Have Skills
Prior medical device manufacturing experience is requiredGMP (21 CFR 820) and ISO 13485 knowledge and experienceAbility to perform internal quality auditsKnowledge of Design control in a FDA regulated industryStatistical knowledge including sampling planscontrol chartsDOEANOVA
Nice-to-Have Skills
Prior experience in supplier management/contract manufacturingExperience in data miningtrend analysis and presentation4+ years of experience preferredPreferred certifications: ASQ CQECMQ/OECQA/CBA
Required Skills
Quality engineeringproduct quality monitoringprocess testingregulatory complianceFDA regulationsISO standardsGMP (21 CFR 820)ISO 13485design controlsupplier managementcontract manufacturingstatistical analysissampling planscontrol chartsDesign of Experiments (DOE)ANOVAdata miningtrend analysiscustomer complaint investigationinternal quality auditsCAPAroot cause analysistechnical documentationCE marking activitiesquality assurancementoring quality technicians
Hard Skills
quality engineeringproduct quality monitoringprocess testingregulatory complianceFDA regulationsISO standardsGMP (21 CFR 820)ISO 13485design controlsupplier managementcontract manufacturingstatistical analysissampling planscontrol chartsDesign of Experiments (DOE)ANOVAdata miningtrend analysiscustomer complaint investigationinternal quality auditscorrective and preventive actions (CAPA)root cause analysistechnical documentationCE marking activitiesquality assurancementoring quality technicians
Soft Skills
responding to day-to-day production and customer quality issuesroot cause analysis facilitationcross-functional collaborationexcellent interpersonal skillsself-motivationproactive approach to quality assuranceteam leadership and mentoringguidance and trainingperformance feedbackcustomer satisfaction focus
Certifications
Preferred
ASQ CQECMQ/OECQA/CBA
Keywords for Your Resume
Quality Engineering Supervisorquality engineering supervisormedical device manufacturingFDA regulationsISO 13485GMP (21 CFR 820)21 CFR 820design controlsupplier managementcontract manufacturerscontract manufacturinginternal quality auditsquality auditingroot cause analysiscorrective and preventive actions (CAPA)CAPAcustomer complaintscustomer satisfactionsampling planscontrol chartsDesign of Experiments (DOE)DOEANOVAdata miningtrend analysisCE markingCE marking activitiesquality techniciansmentorquality assurance
Deal Breakers
Prior medical device manufacturing experience is required, Must have GMP (21 CFR 820) and ISO 13485 knowledge and experience, Must be able to perform internal quality audits
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