Director Quality

Thermo Fisher Scientific seeks a Director of Quality to lead quality assurance and compliance at its Middletown, Virginia clinical diagnostics facility. The role involves managing the quality management system, serving as primary regulatory contact, and directing a quality team while ensuring adherence to FDA, IVDR, ISO 13485, and other global standards.

Responsibilities

• Serve as Management Representative and primary regulatory correspondent for FDA, Notified Bodies, and customer audits
• Develop and oversee quality management system strategies ensuring sustained regulatory compliance
• Lead quality assurance team; establish personnel plans, annual goals, and quality improvement initiatives
• Partner with manufacturing, technical operations, and commercial functions on quality system requirements
• Interact with customers and OEM partners on quality agreements and product-related quality matters

Requirements

• Minimum 10 years quality/regulatory experience; 5+ years leading quality/regulatory function
• Undergraduate degree in life science or biomedical engineering preferred
• Demonstrated leadership capabilities with organizational and process change experience
• Strong understanding of QMS standards and medical device regulations including ISO 13485:2016
• Experience representing organizations in FDA inspections and regulatory audits
• Knowledge of in vitro diagnostics (IVD) product development and manufacturing