Director Quality Management Systems

The 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 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 closely 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.

Quality Management System Leadership

1. Lead all site-level QMS activities ensuring alignment with Enterprise policies and full compliance with regulatory requirements.

2. Maintain and improve site procedures, work instructions, and controlled documents.

3. 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

4. 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.

5. Establish and maintain Global Unique Device Identification Database (GUDID) & Unique Device Identifier (UDI) system.

6. Support readiness for regulatory changes and industry updates impacting the sites.

7. The ability to determine regulatory strategy with demonstrated experience with FDA 510(k) submission requirements - and a proven track record of FDA Clearance(s).

8. Drive continuous improvement initiatives and foster a culture of quality, accountability, harmonization and collaboration.

9. 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

Site Management Review Owner

1. Serves as the Site Management Review Program Owner, responsible for planning and executing Management Review for the facility

2. Coordinate collection, analysis, and presentation of site data including:

   • Production and process controls metrics

   • Nonconformance and process metrics

   • CAPA effectiveness, Audits outcomes, Supplier SCARs

   • Complaints Management trends

   • Resource needs and improvement priorities

3. Ensure actions items are documented, tracked, and closed per ISO 13485 and 21 CFR 820.20 requirements

   Design & Development (Design Controls)

4. Supports R&D and cross-functional teams in applying design controls from feasibility through design transfer.

5. Ensure design transfer to production includes validation of processes, review and approval of methods, training and documentation.

6. 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.

7. Ensure robust processes for design controls including software as a medical device and post market surveillance and field actions.

   Production Process Monitoring and Controls

8. Establish processes and procedures, work instructions, and templates for production and process controls programs per FDA 21 CFR Part 820.70

9. 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.

10. Implement and manage control tools including control charts, run charts, track and analyzing production data for trends, deviations, and improvement opportunities.

11. Ensure robust data management practices for accurate tracking, analysis, and reporting of production metrics.

12. 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.

13. Oversee the quality of incoming materials and components through the supplier audits, quality checks, and strong supplier relationships ensuring that all inputs meet required standards.

14. Provide quality assurance guidance for developing production including receiving and inspection reviews, material non-conformance investigations, standard operating procedures and work instructions.

15. In collaboration with procurement and supplier Quality function, provide input to SCAR investigations and manage supplier performance management

16. Ensure that all production equipment is properly calibrated and maintained according to established procedures, master schedule, and supporting process control and product quality.

17. Ensure equipment qualification, process validation (IQ/OQ/PQ) and process control plans are implemented and maintained

18. Collaborate with cross-functional partners with change controls related to processes, equipment, production software, test methods, and post-market activities.

19. Manage production related document change requests, work instructions updates, and training records reviews.

    Leadership, Training, and Culture of Quality

20. Lead. Monitor, and develop the site Quality team

21. Provide training, coaching, and compliance support to cross-functional site personnel

22. Foster a culture of Quality, data integrity, problem-solving, and continuous improvements across the site

Education

Bachelor's Degree in Life Sciences, engineering, or related technical field; Master's Degree in Life Sciences or other related field

Preferred Technical Training

• ASCP Certification

• Regulatory Affairs Certification (RAC) or American Society for Quality (ASQ) certification

• ISO 13485 Certification

ASQ CSQE (Certified Software Quality Engineer) or medical device related certification, or CSV/GAMP 5 training

Required WorkExperience:

• Required Work Experience:

• 10+ years in a regulated healthcareenvironment or medical device field

• 5+ years in quality assurance leadership in a regulated healthcare environment, with focus on regulations, quality systems, and processes.

• Hands-on experience with authoring, review, and implementation of Quality policies and procedures

• Experience leading audits, supporting inspections, and owning Management Reviews

• Preferred Work Experience:

• 5+ years in an FDA-regulated environment

• Physical and Mental Requirements:

Preferred Work Experience:

• RACCertificationpreferredbutnotrequired.

Knowledge:

• Broad-based technical knowledge and skills in diverse areas of business such as quality engineering, quality assurance, quality systems, regulatory affairs, laboratory operations, GCP, and GMP operations.

• Demonstrated knowledge of design controls, risk management, and regulatory compliance framework.

• Demonstrated Experience applying medical device regulations (e.g., IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15189, cGMP, CAP, and CLIA).

Skills:

• In-depth knowledge of QMS standards and regulatory requirements relevant to manufacturing

• Proficient analytical thinking, technical writing, and problem-solving capabilities

• Excellent cross-functional collaboration skills

Excellent communication skills with ability to engage operators through senior leadership.