Common questions about quality assurance jobs careers in the medical device industry. Jobs are aggregated daily from multiple sources and filtered to this category.
- What does a medical device QA manager do?
- A QA manager oversees the quality management system and ensures regulatory compliance. Key responsibilities include: QMS Management - Maintaining ISO 13485 and 21 CFR 820/QMSR compliance, Audit Management - Coordinating FDA, Notified Body, and internal audits, CAPA Oversight - Managing corrective and preventive action system, Document Control - Overseeing controlled documents and records, Training - Developing and delivering quality training programs, Management Review - Preparing and presenting quality metrics to leadership, Supplier Quality - Overseeing supplier qualification and monitoring.
- What qualifications are needed for QA manager jobs?
- QA management positions typically require: Education: Bachelor's in life sciences, engineering, or quality management. Master's preferred for director roles. Experience: 5-8 years for manager, 10+ years for director level. Knowledge: ISO 13485, 21 CFR Part 820, EU MDR/QMSR, ISO 14971, regulatory submission experience. Certifications: CQA (Certified Quality Auditor), RAB-QSA/LA (Lead Auditor), RAC (Regulatory Affairs Certification) valued. Skills: Leadership, audit management, process improvement, regulatory interpretation.
- What is the salary range for QA jobs in medical devices?
- Medical device QA salaries by level: QA Specialist (2-5 years): $70,000-$95,000, Senior QA Specialist (5-8 years): $90,000-$120,000, QA Manager (7-10 years): $120,000-$155,000, QA Director (10+ years): $155,000-$195,000, VP Quality: $200,000-$280,000+. QMSR and EU MDR expertise commands 10-15% premium. Companies in audit remediation situations often pay above market.
