Manager, Quality Operations (CDx/GMP)

Quest Diagnostics•San Juan Capistrano, CA

About The Position

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.

Requirements

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.
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.
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 skills
Strong communication skills for effective interaction with internal teams’ suppliers, and regulatory bodies

Nice To Haves

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.

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 execution
Create 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.

Benefits

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