Position Details
About this role
This role involves supporting external and internal audits to ensure compliance with ISO 13485 and other medical device regulations, acting as a subject matter expert in quality systems.
Key Responsibilities
- Conduct audits
- Assess compliance
- Perform root cause analysis
- Lead CAPA processes
- Support regulatory assessments
Technical Overview
The environment includes GXP regulated quality management systems, ISO 13485 standards, and regulatory audits for medical devices and pharmaceuticals.
Ideal Candidate
The ideal candidate is a mid-level quality engineer with over 5 years of experience in GXP regulated environments, holding ISO 13485 Lead Auditor certification, with strong auditing and regulatory compliance skills.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Required
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 5 years of industry experience, No ISO 13485 Lead Auditor certification, Lack of experience with medical device regulations
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