Senior QA Auditor
About The Position
Bachelor's degrees at a minimum. ISO 13485 Lead Auditor certification is required. Minimum of five (5) years of experience in the medical device or pharmaceutical industry, specifically within quality systems. Senior-level experience in quality auditing, with the ability to independently plan, execute, and close audits. Demonstrated experience conducting internal audits and supporting or managing external audits, including audits with regulatory bodies and notified bodies (e.g., FDA, TÜV). Strong working knowledge of quality systems and ISO 13485 requirements. Excellent written communication skills, with experience writing audit reports, findings, and documentation. Strong verbal communication and questioning skills, with the ability to critically assess processes and drive improvement. Proven ability to work cross‑functionally, collaborate effectively with stakeholders, and provide updates to management. Proven project management experience
Requirements
- Bachelor's degrees at a minimum
- ISO 13485 Lead Auditor certification is required
- Minimum of five (5) years of experience in the medical device or pharmaceutical industry, specifically within quality systems
- Senior-level experience in quality auditing, with the ability to independently plan, execute, and close audits
- Demonstrated experience conducting internal audits and supporting or managing external audits, including audits with regulatory bodies and notified bodies (e.g., FDA, TÜV)
- Strong working knowledge of quality systems and ISO 13485 requirements
- Excellent written communication skills, with experience writing audit reports, findings, and documentation
- Strong verbal communication and questioning skills, with the ability to critically assess processes and drive improvement
- Proven ability to work cross‑functionally, collaborate effectively with stakeholders, and provide updates to management
- Proven project management experience
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What This Job Offers
Job Type
Full-time
Career Level
Senior
