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

Job Description

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 objects, 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

Inspection, Testing, and Data Management

Equipment Calibration and Maintenance

Document Control and Compliance

Continuous Improvement and Process Optimization

Qualifications :

Required WorkExperience :

Preferred Work Experience :

Physical and Mental Requirements :

Knowledge :

Skills :

41979

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.