Director Quality Management at Quest Diagnostics

Job Description

Director, Quality Management, serves as the site Quality Leader. This role is responsible for implementing, maintaining, and continuously improving the Quality Management Systems (QMS) to ensure full compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and cGMP requirements.

The Director also ensures compliance of the Quality, complaints, validation, and manufacturing operations, and is accountable for coordinating site Management Review, internal audits, CAPA activities, Quality oversight of day-to-day production.

This role partners with laboratory operations, Enterprise Quality and Regulatory, Legal Regulatory, Procurement, technology teams to support safe, compliant, and efficient design and development, and manufacturing of Medical Devices.

Responsibilities

Quality Management Leadership

• Drive site-level harmonization, implementation, integration across site operations, and compliance with Quality Management System Regulation (QMSR) of all processes to ensure a unified, inspection-ready quality system.
• Maintain and improve site procedures, work instructions, and controlled documents.
• Ensure the effectives of QMS subsystems such as Design controls, Risk Management, Calibration, Equipment controls, change control, Complaint Handling, Medical Device Reporting, and Post Market Surveillance
• Establish and maintain a fully compliant complaint handling process including all provisions for Adverse Event reporting (i.e., 21 CFR 803, Medical Device Reports) for all products commercialized by the company.
• Establish and maintain Global Unique Device Identification Database (GUDID) & Unique Device Identifier (UDI) system.
• Support readiness for regulatory changes and industry updates impacting the sites.
• The ability to determine regulatory strategy with demonstrated experience with FDA 510(k) submission requirements – and a proven record of FDA Clearance(s).
• Drive continuous improvement initiatives and foster a culture of quality, accountability, harmonization, and collaboration.
• Collaborate with Medical Quality, R&D, Vendors, Manufacturing, Lab Operations, Legal, Regulatory, and other cross-functional partners to drive adherence to global regulations for devices.
  
  

Design & Development (Design Controls)

• Supports R&D and cross-functional teams in applying design controls from feasibility through design transfer.
• Ensure design transfer to production includes validation of processes, review and approval of methods, 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.
• Ensure robust processes for design controls including software as a medical device and post market surveillance and field actions.
  
  

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, track and analyzing production data for trends, deviations, and improvement opportunities.
• 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.
• 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 manage supplier performance management.
• Ensure that all production equipment is properly calibrated and maintained according to established procedures, master schedule, and supporting process control and product quality.
• Ensure equipment qualification, process validation (IQ/OQ/PQ) and process control plans are implemented and maintained.
• Collaborate with cross-functional partners with change controls related to processes, equipment, production software, test methods, and post-market activities.
• Manage production related document change requests, work instructions updates, and training records reviews.
  
  

Site and Product Registration Management

• Ownership of registration updated for new products, manufacturing changes, and site modifications to ensure uninterrupted market access, regulatory compliance, and inspection readiness.
• Ensure accurate establishment registration, device listing, and timely maintenance of regulatory records.
  
  

Complaint Handling Management, Medical Device Reporting (MDRs), and Recalls, Corrections, and Removals Management

• Provide oversight of Complaint Handling, MDR, and Recalls, Corrections, and Removals management ensuring timely intake, evaluation, investigation, escalation, and execution of all post-market actions.
• Lead risk-based assessment of complaints, adverse events, and post-market signals to determine reportable events, preparation of MedWatch reports, management of follow-up requests from FDA and other regulatory authorities.
• Determine whether Recalls, Corrections, or Removals are required, including field notifications, product retrieval, customer communication, traceability, management visibility, and effectiveness checks.
• Maintain complete and compliant documentation for all complaints, MDRs, and field actions, ensuring audit readiness.
• Monitor complaint trends, MDR triggers, and post-market surveillance data to proactively identify and escalate potential product and process risks.
  
  

Qualifications

Required Work Experience:

• 10+ years of experience in Quality Assurance with demonstrated track-record of accomplishments as a Quality Assurance Regulatory Leader.
• Demonstrated experience with the establishment / management of (21 CFR 801, 803, 806, 807, 820, etc.)
• The ability to determine regulatory strategy with demonstrated experience with FDA 510(k) submission requirements – and a proven track record of FDA Clearance(s).
• Must have excellent communication skills to work with functional areas within the company.
• Experience leading audits, supporting inspections, and owning Management Reviews
  
  

Preferred Work Experience

• RAC Certification preferred but not required.
  
  

Skills

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of governmental regulations.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures.
• In-depth knowledge of QMS standards and regulatory requirements relevant to manufacturing
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions
• Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills.
• Provide training, coaching, and compliance support to cross-functional site personnel.
• Foster a culture of Quality, data integrity, problem-solving, and continuous improvements across the site.
• Exceptional cross-functional team leadership skills and ability to work in close collaboration with others
• Strong organization and planning skills as well as strong attention to detail
• Ability to work independently with limited supervision, adapt to change and manage multiple tasks
• Ability to analyze, define and effectively convey difficult and complex issues in a way that accurately communicates the issues to leadership and external business partners
• Ability to solve problems and make decisions on complex issues, often in a cross-functional team setting
  
  

About The Team

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.