Position Details
About this role
This role involves leading quality assurance activities, risk management, and validation efforts within the medical device division, ensuring compliance and supporting regulatory audits.
Key Responsibilities
- Lead quality deliverables
- Manage risk and validation activities
- Support regulatory audits
- Implement quality system improvements
- Mentor junior staff
Technical Overview
Focus on ISO 14971 risk management, design validation, quality systems, and process improvement methodologies like DMAIC and Six Sigma.
Ideal Candidate
The ideal candidate is a senior quality engineer with at least 5 years of experience in medical device quality assurance, strong knowledge of ISO 14971, risk management, and validation processes, and experience supporting regulatory audits.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with ISO 14971, No background in medical device quality assurance, Less than 5 years of relevant experience, No experience with regulatory audits
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