Position Details
About this role
This role involves supporting medical device product development from concept to commercialization, ensuring safety, quality, and regulatory compliance.
Key Responsibilities
- Lead quality deliverables
- Ensure compliance with ISO 14971
- Support risk management activities
- Mentor engineers in quality methodologies
- Assist in regulatory audits
Technical Overview
Focuses on quality assurance, risk management, validation, and regulatory standards within the medical device industry, utilizing systematic methodologies like DMAIC and Six Sigma.
Ideal Candidate
The ideal candidate is a senior quality engineer with extensive experience in medical device development, risk management, and regulatory standards such as ISO 14971. They possess strong leadership skills and a systematic problem-solving approach to ensure product safety and compliance.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with ISO 14971, No background in medical device quality, Inability to lead cross-functional teams, No experience with risk management methodologies
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