Position Summary:
We are seeking a Senior Quality Engineer to lead and support quality assurance activities throughout the product lifecycle - from design and development to manufacturing and post-market surveillance. The ideal candidate will bring a strong background in medical device quality systems, regulatory compliance, and risk management.
Key Responsibilities:
- Ensure compliance with applicable regulatory standards including FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
- Lead quality engineering activities such as Design Control, Risk Management (ISO 14971), CAPA, Nonconformance Management, and Root Cause Analysis.
- Collaborate with R&D and Manufacturing teams to ensure quality is built into design and production processes.
- Review and approve product development documentation including Design History Files (DHF), Device Master Records (DMR), and validation protocols.
- Support internal and external audits (FDA, ISO, Notified Body).
- Develop and implement quality plans, test protocols, inspection procedures, and process validation strategies (IQ/OQ/PQ).
- Monitor and analyze quality data, trends, and metrics to identify opportunities for improvement.
- Serve as a quality representative on cross-functional project teams.
- Train and mentor junior QA staff and team members.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related technical field (advanced degree preferred).
- 5+ years of experience in quality engineering in the medical device industry or similar regulated field.
- In-depth knowledge of ISO 13485, 21 CFR Part 820, MDR, and related quality system regulations.
- Experience with Design Controls, Risk Management (ISO 14971), and CAPA/NCR systems.
- Strong understanding of statistical techniques and quality tools (e.g., SPC, DOE, FMEA, Six Sigma).
- Experience in process validation (IQ/OQ/PQ) and supplier quality management is a plus.
- Excellent organizational, communication, and leadership skills.
- Certified Quality Engineer (CQE), Six Sigma, or other quality certifications preferred.
Benefits:
- Competitive salary and bonus structure
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Flexible work hours and hybrid work options
- Professional development opportunities