Senior Auditor
Insight Global
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. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
Skills and Requirements
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)
$80k - $100k
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