Quest Diagnostics · 20 hours ago
Director Quality Management
Lenexa, KS
Full-time
Onsite
Director/Executive
10+ years expQuest Diagnostics is a leading provider of diagnostic information services. The Director of Quality Management is responsible for implementing and improving the Quality Management Systems to ensure compliance with regulatory requirements and to support the manufacturing of medical devices.
BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine
Responsibilities
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
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
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
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
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
Qualification
Required
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
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
Preferred
RAC Certification preferred but not required
Company
Quest Diagnostics
Quest Diagnostics is a clinical laboratory that offers diagnostic testing, services, and information.
10001+ employees
H1B Sponsorship
Quest Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (59)
2024 (38)
2023 (74)
2022 (56)
2021 (49)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$2.6B2024-08-15Post Ipo Debt· $1.85B
2023-10-30Post Ipo Debt· $750M
1996-12-17IPO
Leadership Team
James Davis
Chief Executive Officer and President
Cecilia McKenney
SVP & Chief Human Resources Officer
Recent News
2026-01-09
Company data provided by crunchbase