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Quality Systems Engineer III - IGS
Systems Engineer
Senior Quality Systems Engineer driving QMS development, implementation, and continuous improvement in a regulated medical device environment, ensuring compliance with FDA, ISO, IEC, and EU MDR standards while harmonizing processes across sites.
About the role
Key Responsibilities
- Lead the development, implementation, and ongoing enhancement of the Quality Management System across multiple sites.
- Ensure full compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR, and ISO 14971, translating regulatory requirements into actionable processes.
- Collaborate with Quality, Regulatory, R&D, and cross‑functional teams to harmonize QMS practices and support product lifecycle activities.
- Conduct risk assessments, audits, and corrective action reviews, driving continuous improvement initiatives.
- Prepare and maintain documentation, reports, and evidence for regulatory inspections and audits.
Requirements
- Minimum 5 years of experience in quality systems within the medical device industry.
- Deep knowledge of FDA, ISO, IEC, and EU MDR regulations and risk management frameworks.
- Strong analytical, problem‑solving, and communication skills.
- Proven ability to lead cross‑functional projects and influence process improvements.
- Experience with QMS software and documentation control systems.