Manager, Quality Operations (CDx/GMP) at Quest Diagnostics
Alert: Scammers may offer fake Quest jobs using LinkedIn and other platforms. Click here to learn more.
Skip to main content
;
Career areas
Phlebotomy Laboratory Specimen processing Drivers Transportation and logistics Customer Service Per diem and on call
Sales Technology Corporate Medical, scientific, and R&D Internships All jobs India based jobs
Who we are
Culture Benefits Upcoming events
What we do
Innovation and insights Start your career with Quest Veterans at Quest Job seeker resources
Job alerts Saved jobs My profile Current employees
Search
Search by Keyword
Search by Location
5 miles 15 miles 25 miles 35 miles 50 miles
Radius
Search
More: Impact Discover a role that empowers some of life's most important healthcare decisions.
Manager, Quality Operations (CDx/GMP)
Apply Save roleSaved role
Category Laboratory Location San Juan Capistrano, California Job function Operations Job family Quality Assurance
Shift Day Employee type Regular Full-Time Work mode On-site
Job DescriptionPay Range: $125,000.00 - $145,000.00 / yearSalary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.Benefits Information:We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:· Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours· Best-in-class well-being programs· Annual, no-cost health assessment program Blueprint for Wellness· healthyMINDS mental health program· Vacation and Health/Flex Time· 6 Holidays plus 1 "MyDay" off· FinFit financial coaching and services· 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service· Employee stock purchase plan· Life and disability insurance, plus buy-up option· Flexible Spending Accounts· Annual incentive plans· Matching gifts program· Education assistance through MyQuest for Education· Career advancement opportunities· and so much more!The Quality Operations Manager, Quality Operations leads a team responsible for execution and oversight of production and process control quality activities within an IVD medical device manufacturing environment. This role combines people leadership with strong technical and operational accountability and ensures that quality engineering activities are executed effectively, consistently, and in compliance with FDA QMSR, ISO 13485, and GMP expectations. The role is expected to make timely quality decisions, manage escalations, and maintain a high state of operational readiness.Responsibilities: Lead, develop, and direct a team of quality engineers or equivalent personnel supporting receiving inspection, acceptance activities, process validation, change control, supplier quality interfaces, investigations, and CAPA executionCreate an operating environment that is disciplined execution, responsive, and audit ready.Ensure appropriate quality oversight of manufacturing operations and production/process controls across assigned products, lines, or operational areas.Review and approve nonconformances, CAPAs, validation documentation, change records, and related quality records in accordance with delegated authority and internal procedures.Provide escalation support for significant product, processes, equipment, supplier, or compliance issues and make timely decisions regarding containment, disposition, validation, and corrective action needs.Partner with Manufacturing, Equipment Engineering, Supply Chain, Supplier Quality, R&D, and Regulatory Affairs to support execution of design transfer, process improvement, and manufacturing readiness activities.Ensure training, workload prioritization, and execution discipline within the team, while maintaining quality and timeliness standards.Monitor quality metrics and operational trends, identify systemic issues, and drive focused actions to improve process robustness, compliance, and inspection readiness.Lead preparation for internal audits, external audits, and regulatory inspections involving manufacturing and production/process control topics.Provide management review inputs, including quality data, trend analysis, significant risks, and status of key remediation activities.Promote strong documentation practices, risk-based thinking, and technical rigor across day-to-day operations.Qualifications: Required WorkExperience: 10+ years of relevant experience in quality engineering, quality operations, or manufacturing quality in a medical device or IVD environment, including prior leadership experience.Strong knowledge of FDA QMSR, ISO 13485, GMPs, validation, supplier controls, production/process controls, and quality system interfaces.Demonstrated success leading teams and managing complex operational quality issues in manufacturing settings.Ability to balance technical rigor, compliance expectations, and practical business execution.Deep expertise in FDA QMSR, ISO 13485, GMPs, production and process controls, validation, and manufacturing quality decision-making.Strong experience with IVD design transfer, validation strategy, supplier quality interfaces, and management of complex quality system events.Recognized ability to influence technical and operational decisions across functions without sole reliance on formal authority.Strong understanding of design control, DHF / technical documentation, design change governance, and lifecycle quality support for IVD products.Strong facilitation, influencing, and structured problem-solving skills.Preferred Work Experience: Experience with multi-product or multi-technology IVD manufacturing environments and broad familiarity with risk management, measurement systems, and statistical analysis.ASQ certification or equivalent quality engineering credential.Physical and Mental Requirements: Strong attention to detail for thorough documentation to ensure consistency in documentation. Excellent problem-solving skills to identify and address quality issues effectively. Ability to manage multiple projects to meet deadlines while maintaining accuracy. Knowledge: Strong working knowledge of FDA QMSR, ISO 13485, ISO 14971,GMP, and practical application of risk-based quality system management.Experience supporting manufacturing scale-up, design transfer, remediation, or inspection-intensive environments.Skills: In-depth knowledge of QMS standards and regulatory requirements relevant to manufacturing Ability to balance speed, compliance, and product quality without compromising patient safety, product performance, or regulatory expectations.Excellent cross-functional collaboration skillsStrong communication skills for effective interaction with internal teams' suppliers, and regulatory bodies61026Quest 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.
Share this job
Facebook X LinkedIn Email
Explore this location Explore
"I love working here because Quest has been my second family and second home. I''ve experienced a wholesome work environment, and good management."
Featured Jobs Recently Viewed Jobs Saved Jobs
Phlebotomist II Manahawkin, New Jersey 06/02/2026
Phlebotomist II Moline, Illinois 06/02/2026
Phlebotomist II Site Lead East Greenville, Pennsylvania 06/02/2026
No jobs have been saved.
No jobs have been saved.
What it's like to work here
Culture Our people contribute to fostering an inspiring and supportive workplace where we empower better health for our customers every day. Through our 11 Employee Business Networks (EBNs) employees can grow, connect, and contribute with professional development, mentorship, EBN program offerings, and community engagement. Each of our Quest Employee Business Networks is open to all employees. View more
Benefits We strive to ensure our people live a healthier lifestyle by offering programs and solutions that help you take care of yourself and those you love. Find out how our benefits give you everything you need to live your best life. View more
Corporate Social Responsibility Report We''re committed to promoting a healthier world, creating an inspiring workplace, and building value for all stakeholders. Discover how we''re making this happen in our annual reports. View more
Job Seeker Resources | Quest Diagnostics No matter where you are in your journey with us, you''re probably curious about our hiring process. With that in mind, check out some of the most frequently asked questions we get from candidates below. View more
Upcoming events | Quest Diagnostics Our events are the perfect way to meet us and discover more about what it means to choose a career with Quest. Here's the place to keep your calendar up-to-date with all the details of our upcoming virtual and in-person events. View more
Innovations and Insights | Quest Diagnostics We're a customer-first organization dedicated to creating a healthier world. We offer an environment that encourages curiosity. Ready to collaborate with us? Explore the areas below or search all open jobs to discover your next meaningful and challenging role. View more
Students & early career | Quest Diagnostics Whether you are transitioning from high school, college or to civilian life after serving in the military, we have programs that can help you reach your goals - and share in the incredible work we do. At the same time, you'll be able to enjoy the satisfaction that comes with joining a network of 50,000 brilliant minds united by a shared passion to build a healthier future. View more
Load more
Why get job alerts? To stay in touch with us, we encourage you to sign up for our job alerts. Once registered, we'll match you with current and future career opportunities. You'll also receive updates about Quest news, events, and other exciting opportunities. Sign up today!
Equal employment opportunity
Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any any other legally protected status . Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary. Quest Diagnostics is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please complete the accommodation request form.
Our company Equal opportunities E-Verify Know your rights NLRA employee rights Los Angeles County FCOE
Our company
About us How we operate What we do Corporate responsibility Culture and belonging Actions and insights Suppliers Shop tests
Locations Careers Investors Specialty labs Newsroom
Connect With Us
Facebook X YouTube LinkedIn Instagram
Site map Privacy Terms Cookie Notice Contact us Language assistance / non-discrimination Asistencia de idiomas / Aviso de no discriminación / Privacy Shield Accessibility
Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third-party marks- and -are the property of their respective owners. 2026 Quest Diagnostics Incorporated. All rights reserved. Image content features models and is intended for illustrative purposes only.