Director, Quality

About This Role

This role involves providing strategic leadership and oversight for the company's global quality systems, with direct responsibility for Quality Engineering at the Audubon (HQ) site, International Operations Quality, and Sterile Manufacturing Quality. The Director ensures compliance with regulatory requirements and alignment with company objectives for product safety, effectiveness, and continuous improvement. The position suits a leader who can collaborate cross-functionally to maintain a culture of quality excellence and operational efficiency across all facilities and international markets.

Responsibilities

• Develop and execute the global quality strategy aligned with company objectives and regulatory requirements
• Provide leadership, mentoring, and development for the Quality Engineering, International Quality, and Sterile Manufacturing Quality teams
• Serve as a senior quality representative in management review, audits, and regulatory inspections
• Drive a culture of accountability, continuous improvement, and proactive risk management
• Oversee product quality engineering, including design assurance, process validation, risk management, and post-market feedback
• Ensure robust CAPA, complaint handling, and nonconformance processes
• Lead validation strategy and ensure compliance with ISO 14971, ISO 13485, and 21 CFR Part 820 requirements
• Support new product development and design transfer to manufacturing
• Oversee quality system compliance at all international manufacturing and distribution sites
• Ensure adherence to global regulatory requirements including MDSAP, EU MDR, Health Canada, PMDA, and TGA
• Harmonize global quality processes and drive consistency across regions
• Support international audits and coordinate responses to regulatory authorities
• Provide oversight of sterilization validation, monitoring, and requalification programs in accordance with ISO 11135 / ISO 11137 / ISO 17665
• Ensure control of cleanroom operations, environmental monitoring, aseptic techniques, and contamination control programs
• Approve sterilization cycles, validations, and deviations
• Support product release and ensure compliance with sterility assurance requirements
• Lead or support internal and external quality audits
• Ensure timely closure of audit findings and CAPA actions
• Implement continuous improvement initiatives to enhance quality system performance and product reliability
• Monitor and report key quality metrics to executive management

Requirements

• Minimum BS degree or equivalent in Science or Engineering
• Minimum of 5 years of experience within Medical Device Quality Assurance/Quality Systems with experience in FDA and CE Notified Body inspections