Position Details
About this role
This role provides technical leadership in service quality for medical devices, focusing on reliability, compliance, and process improvements across the product lifecycle.
Key Responsibilities
- Lead service quality oversight
- Perform root cause analysis
- Ensure regulatory compliance
- Collaborate on reliability improvements
- Support audit readiness
Technical Overview
Involves service quality engineering, root cause analysis, CAPA, and adherence to regulatory standards such as 21 CFR 820.170, ISO 13485, and ISO 14971, supporting field service and reliability improvements.
Ideal Candidate
The ideal candidate is a seasoned service quality engineer with over 7 years of experience in medical device service and reliability, proficient in regulatory standards like 21 CFR 820.170 and ISO 13485. They excel in root cause analysis, CAPA, and cross-functional collaboration to improve field service performance.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 7 years of relevant experience, No background in medical device service quality, Lack of knowledge of regulatory standards, Inability to lead root cause analysis and CAPA
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