Quality Director

Position Summary

The Quality Director provides strategic and operational leadership for the Quality organization within a regulated medical device manufacturing environment. This role is responsible for ensuring the effectiveness of the Quality Management System (QMS), maintaining global regulatory compliance, driving continuous improvement initiatives, and supporting the development and manufacture of safe and effective medical devices. The Quality Director partners closely with Operations, Manufacturing, Engineering, R&D, Regulatory Affairs, and Supply Chain to promote a culture of quality and operational excellence across the organization.

Key Responsibilities

• Lead and develop the Quality organization, including Quality Assurance, Quality Engineering, Supplier Quality, and Validation functions.
• Establish and execute quality strategies, objectives, and performance metrics aligned with business goals.
• Maintain an effective Quality Management System (QMS) compliant with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable regulatory requirements.
• Ensure inspection readiness and lead interactions with FDA, notified bodies, customers, and third-party auditors.
• Oversee quality system processes including CAPA, nonconformance management, complaint handling, internal audits, change control, management review, and document control.
• Partner with Manufacturing and Operations to improve product quality, process capability, yield, and overall manufacturing performance.
• Ensure effective execution of process validation, equipment qualification (IQ/OQ/PQ), test method validation, and risk management activities.
• Lead complex investigations, root cause analyses, and implementation of corrective and preventive actions.
• Direct supplier quality programs, including supplier qualification, auditing, performance monitoring, and supplier corrective actions.
• Support product development, design transfer, and commercialization activities to ensure compliance throughout the product lifecycle.
• Monitor quality performance through data analysis and trend identification to proactively address risks and drive improvement initiatives.
• Champion Lean, Six Sigma, and Operational Excellence methodologies to improve quality, efficiency, and cost performance.
• Build strong cross-functional partnerships while fostering a culture of accountability, compliance, and continuous improvement.

Qualifications

Required

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline.
• 10+ years of progressive quality leadership experience within the medical device industry.
• 5+ years of people leadership experience managing quality teams and organizational performance.
• Strong working knowledge of:
  • FDA Quality System Regulation (21 CFR Part 820)
  • ISO 13485
  • EU MDR
  • ISO 14971 Risk Management
  • Design Controls
  • CAPA Systems
  • Validation Methodologies (IQ/OQ/PQ)
• Demonstrated success leading regulatory inspections and external audits.
• Experience supporting commercial manufacturing operations and product development programs.
• Strong leadership, communication, analytical, and problem-solving skills.

Preferred

• Advanced degree (MS, MBA, or equivalent).
• ASQ certifications such as CQE, CQA, CMQ/OE, or Six Sigma certification.
• Experience supporting Class II and/or Class III medical devices.
• Experience within a high-volume manufacturing or medical device contract manufacturing environment.
• Knowledge of global regulatory requirements and international quality standards.

Key Competencies

• Strategic Leadership
• Quality Systems Management
• Regulatory Compliance
• CAPA & Root Cause Analysis
• Risk Management
• Process Validation
• Supplier Quality Management
• Operational Excellence
• Cross-Functional Leadership
• Change Management
• Talent Development
• Executive Communication