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About the role
Key responsibilities & impact- Own and maintain the NADC Quality Management System in alignment with ISO 13485 and FDA regulatory requirements
- Serve as the designated Quality Management Representative for the NADC
- Ensure QMS processes are established, implemented, maintained, and continuously improved
- Promote awareness of regulatory and customer requirements across the organization
- Ensure compliance with applicable FDA regulations (21 CFR Part 820), ISO 13485, and other global requirements
- Manage internal, external, and corporate audits, including FDA and notified body inspections
- Establish, implement, and optimize inspection methods, sampling strategies, and quality inspection processes
- Define, implement, and monitor Quality KPIs (e.g., deviations, CAPA effectiveness, audit outcomes, etc.)
- Lead, coach, and develop Quality Inspectors, Technicians, and Engineers
Requirements
What you’ll need- Bachelor’s degree in Engineering, Science, or related technical discipline
- 10+ years of progressive experience in medical device or pharmaceutical quality systems
- Demonstrated experience in distribution, logistics, or supply chain quality environments
- Proven experience interacting with FDA and notified bodies during inspections and audits
- Prior leadership experience managing quality teams required
- ASQ certification (CQE, CQA, CMQ/OE) preferred
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management SystemISO 13485FDA regulationsQMS processesQuality KPIsinspection methodssampling strategiesCAPA effectivenessaudit outcomesquality inspection processes
Soft Skills
leadershipcoachingdevelopmentcommunicationorganizational awareness
Certifications
ASQ certificationCQECQACMQ/OE
