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Staff Quality Systems Specialist - Kelly Services
Software Engineer
Experienced Quality Systems Specialist leading ISO 13485 and FDA compliance, CAPA, risk management, and design validation activities for medical device projects.
About the role
Key Responsibilities
- Develop, maintain, and audit quality system documentation to ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
- Lead CAPA investigations, root cause analysis, and corrective actions across product development and manufacturing.
- Perform risk assessments and implement risk mitigation strategies throughout the product lifecycle.
- Coordinate design verification and validation activities, including test planning, execution, and reporting.
- Support internal and external audits, prepare audit findings, and drive timely closure of observations.
Requirements
- 5+ years of quality systems experience in the medical device industry.
- Strong knowledge of ISO 13485, FDA QSR, and related regulatory requirements.
- Proven experience with CAPA, risk management (ISO 14971), and design validation processes.
- Excellent documentation and audit preparation skills.
- Effective communication and ability to work cross‑functionally with engineering, manufacturing, and regulatory teams.
Skills
software developmentsystem designproblem solving