Director Quality Management Systems

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, and technology teams to support safe, compliant, and efficient design and development, and manufacturing of Medical Devices.

• Lead all site-level QMS activities ensuring alignment with Enterprise policies and full compliance with regulatory requirements.
• 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.
• Determine regulatory strategy with demonstrated experience with FDA 510(k) submission requirements – and a proven track 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.

• Serve as the Site Management Review Program Owner, responsible for planning and executing Management Review for the facility.
• 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
• Ensure action items are documented, tracked, and closed per ISO 13485 and 21 CFR 820.20 requirements.

• Support 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 meets quality standards.
• Implement and manage control tools including control charts, run charts, track and analyse 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.
• Oversee the quality of…