Senior Manager, Quality Operations; Medical Device, Production and Process Control

Position: Senior Manager, Quality Operations (Medical Device, Production and Process Control)

Senior Manager, Quality Operations (Medical Device, Production and Process Control)

Join to apply for the Senior Manager, Quality Operations (Medical Device, Production and Process Control) role at Quest Diagnostics.

The Sr. Manager, Quality Operations is a hands‑on tactical Quality leader responsible for ensuring overseeing and enhancing the quality of laboratory production and manufacturing operations, with a specific focus on production processes and the control elements of the Quality Management Systems (QMS). This role ensures that all production activities comply with industry standards, regulatory requirements, and internal Quality objectives, driving continuous improvement and operational excellence.

This is an Onsite position.

Responsibilities Design Control & Development Quality Oversight

• Supports R&D and cross‑functional teams in applying design controls from feasibility through design transfer.
• Ensure design transfer to production includes validation processes, review and approval of methods, and training and documentation.
• Participate and contribute to design inputs/outputs reviews, verification and validation planning, design transfer, and design history to ensure quality and regulatory integration throughout the device development and manufacturing.

Production Process Monitoring and Controls

• Establish processes and procedures, work instructions, and templates for production and process controls programs per FDA 21 CFR Part 820.70.
• Oversee the continuous monitoring of the production processes using methodologies such as Statistical Process Control (SPC) to ensure operation remains within the defined parameters and meet quality standards.
• Implement and manage control tools including control charts, run charts, tracking and analyze production data for trends, deviations, and improvement opportunities.

Inspection, Testing, and Data Management

• Ensure robust data management practices for accurate tracking, analysis, and reporting of production metrics.
• Direct the identification, investigations, documentation and resolution of nonconformances in production, ensuring timely implementation of corrective and preventive actions (CAPA) to address root causes and prevent recurrence.
• Oversee the quality of incoming materials and components through supplier audits, quality checks, and strong supplier relationships, ensuring that all inputs meet required standards.
• Provide quality assurance guidance for developing production including receiving and inspection reviews, material non‑conformance investigations, standard operating procedures and work instructions.
• In collaboration with procurement and supplier quality function, provide input to SCAR investigations and supplier performance management.

Equipment Calibration and Maintenance

• Ensure all production equipment is properly calibrated and maintained according to established procedures, master schedule, and supporting process control and product quality.
• Review and approve equipment IQOQPQ protocols and reports, calibrations, and maintenance records.
• Take ownership of implementation and maintenance of change control program requirements for production and process controls activities.
• Collaborate with cross‑functional partners to initiate and close out change controls related to processes, equipment, production software, test methods, and post‑market activities.
• Lead equipment investigations and documentation of nonconformances, deviations, out‑of‑specifications results, and CAPA effectiveness reviews.
• Manage production‑related document change requests, work instruction updates, and training records reviews.

Document Control and Compliance

• Maintain accurate and up‑to‑date documentation of production processes, Quality standards, inspection results, and process changes to ensure traceability and compliance with industry and regulatory standards.

Continuous Improvement and Process Optimization

• Drive continuous improvement initiatives using Lean, Six Sigma methodologies to reduce waste, minimize defects, and enhance process efficiency.
• Lead root cause analysis and process improvement projects to optimize production workflows and outcomes.
• Collaborate with…