Common questions about quality engineer jobs careers in the medical device industry. Jobs are aggregated daily from multiple sources and filtered to this category.
- What does a medical device quality engineer do?
- Medical device quality engineers ensure products meet regulatory and quality standards throughout development and manufacturing. Key responsibilities include: Design Quality - Supporting design controls per 21 CFR 820.30, risk management per ISO 14971, Verification & Validation - Developing and executing V&V protocols for software and hardware, Process Validation - IQ/OQ/PQ protocols for manufacturing processes, Supplier Quality - Auditing and qualifying suppliers, CAPA - Leading corrective and preventive actions, Documentation - Maintaining DHF, DMR, and DHR records.
- What qualifications are needed for QE jobs?
- Quality engineer positions typically require: Education: Bachelor's in engineering (biomedical, mechanical, electrical) or life sciences. Experience: 2-5 years for mid-level, 5-10+ for senior roles. Knowledge: ISO 13485, 21 CFR Part 820, ISO 14971 risk management, IEC 62304 (software), IEC 60601 (electrical). Skills: Statistical analysis, root cause analysis, technical writing, project management. Certifications: ASQ CQE (Certified Quality Engineer), Six Sigma Green/Black Belt valued.
- What is the salary range for quality engineer jobs?
- Medical device QE salaries by experience: Entry-level (0-2 years): $65,000-$80,000, Mid-level (3-5 years): $80,000-$105,000, Senior (5-10 years): $105,000-$135,000, Principal/Staff (10+ years): $130,000-$160,000, Manager: $140,000-$175,000. Specialized roles like software V&V or supplier quality often command 10-15% premium. Boston, San Francisco, and Minneapolis offer highest compensation.
