Manager, Quality Operations (CDx/GMP)

Pay Range: $125,000.00 - $145,000.00 / year

Salary 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.
 

• 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.

Required Work Experience: 

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