Manager, Quality Systems

Responsibilities

• Lead, mentor, and develop Quality Systems team members, fostering a culture of quality, accountability, collaboration, and continuous improvement
• Partner cross-functionally to investigate quality issues, interpret data trends, and drive timely, risk-based decisions
• Own and maintain the Document Control system, ensuring controlled documents remain accurate, current, compliant, and properly version-controlled
• Administer and continuously enhance the company training program, ensuring timely completion, training effectiveness, and maintenance of compliant training records
• Own the CAPA program, including driving timely resolution of aging CAPAs, ensuring robust root cause investigations, and monitoring closure effectiveness and metrics
• Lead Nonconformance (NC) processes from initiation through final disposition and closure, ensuring timely and compliant execution
• Support EU MDR compliance activities in partnership with external regulatory consultants, including CERs, PSURs, and PMS deliverables
• Maintain quality documentation and records necessary to support BSI certification activities and ongoing CE mark compliance
• Support system validation activities, process improvements, and ongoing enhancements to quality systems and tools as needed
• Coordinate CHAP accreditation activities and ongoing DME compliance requirements, including preparation for and management of external audits
• Partner with external auditors and regulatory agencies to support inspections, audits, and compliance readiness activities
• Ensure the Quality Management System remains compliant with FDA, ISO 13485, CHAP, EU MDR, and other applicable regulatory and quality standards

Qualifications

• 5+ years of progressive Quality Assurance experience within the medical device industry, including experience in regulated manufacturing environments
• 2+ years of people leadership or management experience, with demonstrated ability to lead and develop high-performing teams
• Strong working knowledge of ISO 13485, 21 CFR Part 820, FDA Quality System Regulations, and EU MDR requirements
• Hands-on experience utilizing eQMS and PLM systems to support quality and compliance initiatives
• Ability to interpret, implement, and adapt to evolving regulatory requirements, including DME quality system standards
• Solid understanding of core quality processes, including CAPA, nonconformance management, complaint handling, change control, and internal auditing
• Experience partnering with external auditors and regulatory agencies, including BSI, FDA, CHAP, or equivalent organizations
• Demonstrated ability to manage multiple priorities and drive execution in a fast-paced, evolving environment
• Strong analytical and problem-solving skills, with the ability to identify trends, summarize findings, and communicate recommendations to leadership