Senior Specialist, Quality Systems Enterprise

Quest Diagnostics • West Palm Beach, FL

3d

About The Position

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.

Requirements

• Subject Matter Expert (SME) in regulatory compliance and quality systems
• Knowledge of FDA regulations, including 21 CFR Part 820, 21 CFR Part 803, ISO 13485, and ISO 14971

Responsibilities

• End-to-end administration, governance, and continuous improvement of key elements of the Quality Management System (QMS)
• Primary accountability for post-market surveillance processes
• Primary accountability for eQMS functionality within Quest Diagnostics
• Serve as a Subject Matter Expert (SME) in regulatory compliance and quality systems
• Ensure alignment with FDA regulations, including 21 CFR Part 820, 21 CFR Part 803, ISO 13485, and ISO 14971
• Influence quality system design
• Influence inspection readiness
• Influence cross-functional quality outcomes

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed