Senior Auditor

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.

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Required Skills & Experience

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


Nice to Have Skills & Experience

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)


Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.