Senior Auditor

Job Description

Eurofins E&E is seeking a Senior Medical Device Auditor with extensive experience in medical device auditing to support audit and certification activities. This individual will bring deep technical and regulatory expertise, along with the ability to lead audits and contribute at a senior level.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

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• 8+ years of Medical device auditing experience (senior to be a leader)
• Ideally transitioned from manufacturing (Medtronic, GE Healthcare, Stryker, etc.) → auditing / quality / compliance
• Has audited real products and systems, not just documentation
• Must be active medical (leave nonactive and IVDR out of the program)
• Therapy, electrical, surgical, things that do work
• MDR + ISO 13485 expertise
• Strong experience with EU MDR and ISO 13485 QMS
• Understands regulatory + compliance requirements in practice
• Notified Body / external audit exposure
• Experience with notified bodies, NRLT labs, or equivalent external audit environments
• Technical auditor (not just quality systems)
• Can assess device design, manufacturing, and risk
• Not limited to checklist or process-only auditing
• Willingness to travel (~70%) + perform MDSAP audits from BSI, TUV, DEKRA
• Certifications or credentials related to medical device auditing or quality
• Experience with FDA 21 CFR 820, global regulatory environments
• Leadership experience (leading audits, mentoring auditors)