Senior Quality System Manager – ISO 13485 & FDA
Listed on 2026-10-15
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Quality Assurance - QA/QC
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Healthcare
Entegee is seeking an experienced Quality Management Systems leader to independently set up and maintain an ISO 13485–compliant QMS for a medical device manufacturing site in New Jersey. You will own FDA site registration, audits, and ongoing regulatory maintenance, while coordinating with notified bodies and customers.
The role requires deep expertise in ISO 13485, FDA QSR, and ISO 14971 risk management, with a track record of leading successful certifications and surveillance.
For the Senior Quality System Manager – ISO 13485 & FDA position at Entegee, we are reviewing applications now.
Step into the Senior Quality System Manager – ISO 13485 & FDA role at Entegee in West Caldwell, NJ, United States and grow with us.
Please review the full job details above before applying.
If your experience matches this role, we encourage you to apply.
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