Senior Specialist, Quality Systems Enterprise

 Posted a month ago
     
⭐ 10+ years experience
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AI Summary

Responsible for the end-to-end administration, governance, and continuous improvement of the Quality Management System, specifically focusing on post-market surveillance and eQMS functionality. Acts as a Subject Matter Expert to ensure alignment with FDA and ISO regulatory standards.

The Senior Specialist, Quality Systems is a senior-level individual contributor responsible for end-to-end administration, governance, and continuous improvement of key elements of the Quality Management System (QMS), with primary accountability for post-market surveillance processes and eQMS functionality within Quest Diagnostics.

This role serves as a Subject Matter Expert (SME) in regulatory compliance and quality systems, ensuring alignment with FDA regulations, including 21 CFR Part 820, 21 CFR Part 803, ISO 13485, and ISO 14971. The position has significant influence on quality system design, inspection readiness, and cross-functional quality outcomes.


Quest Diagnostics honors our service members and encourages veterans to apply.

While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.

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