Purpose

The Manager, Quality is responsible for leading, maintaining, and improving the Quality Management System (QMS) to ensure compliance with applicable regulatory, statutory, and quality requirements while driving the business with competitive KPIs and results. This role provides strategic and operational leadership to ensure product and service quality, regulatory readiness, and continuous improvement across the organization while supporting business objectives and customer expectations.  This role leads cross-functional initiatives, oversees audits and inspections, manages key quality system elements, and ensures alignment between quality and regulatory requirements (e.g., ISO 13485, 21 CFR 820, EU MDR/IVDR, etc.).

Essential Functions

•         People management:  Manage and coach quality professionals that report to you, ensuring appropriate workload distribution, performance development, and technical competency. Ensure deadlines are met and KPIs are industry leading. 

•         Matrix Management:  Ability to work in a highly matrix environment. Lead matrix teams and drive decisions that deliver results for the business.

•         Using AI to intelligently balance team workloads, enable delivery of business goals, and propel the organization toward industry‑leading innovation and results.

•         Develop, maintain, and improve the Quality Management System (QMS) in accordance with regulatory requirements and industry standards.

•         Ensure compliance with applicable regulations (e.g., FDA, ISO, ICH, EU MDR/IVDR and lead internal and external audits.

•         Provide quality leadership and guidance for document control, training, product lifecycle activities, including design changes, risk management, post‑market surveillance, and corrective and preventive actions (CAPA).

•         Partner with colleagues to ensure compliance on cybersecurity and country-specific laws.

•         Collaborate with cross-functional teams (R&D, Operations, Regulatory, Support, Services, Marketing, etc.) to support product development and commercialization.

•         Monitor changes in regulatory requirements and ensure timely updates to internal procedures and systems.

•         Train and mentor quality staff and ensure organizational readiness for inspections.

•         Lead continuous improvement initiatives to increase quality, efficiency, and compliance.

•         Serve as quality/regulatory representative in project teams and strategy discussions.

·       Serve as a generalist and primary quality liaison during audits, inspections, and assessments conducted by regulatory authorities, customers, and notified bodies.

·       Review and approve quality records, investigations, and reports, ensuring timely escalation and resolution of quality issues.

·       Monitor KPIs for trends, assess impact to the organization, and drive proactive updates to systems, procedures, and training.

·       Support quality planning for new products, services, and geographic expansions.

Skills needed to be successful

·       Strong leadership (matrix and direct) and people‑management skills, including coaching, performance management, and talent development.

·       Understanding of medical device / health care / laboratory business and worldwide regulatory requirements necessary in these areas

·       Strong working knowledge of quality systems and regulatory requirements in regulated healthcare, medical device, laboratory, or life sciences environments.

·       Ability to interpret regulations and standards and translate them into practical, scalable quality processes.

·       Excellent English written and verbal communication skills, with the ability to influence across organizational levels.

·       Strong analytical, problem‑solving, and decision‑making capabilities.

·       High attention to detail combined with the ability to think strategically.

·       Proficiency with quality systems, electronic QMS tools, and software‑based workflows.

Required Experience & Education

•         Bachelor's degree in a science, engineering or healthcare-related field

•         5–8+ years of experience in quality assurance and/or regulatory affairs, preferably in medical device, or software.

•         People management experience: leading teams both direct and matrix.

•         Demonstrated experience supporting audits, inspections, and regulatory compliance activities.

•         Knowledge of regulatory requirements and where to find these requirements

•         Experience leading quality initiatives or projects.

•         Experience in AI (e.g. use of AI to enhance team performance and training).

Physical Requirements

·       Hybrid work (minimum 3 days per week in office).

·       Work is performed in a normal office setting with minimal exposure to health or safety hazards.  Prolonged periods of sitting at a desk and working on a computer.

·       International travel may be required

·       Moderate lifting/carrying 15-44 lbs.; use of fingers; walking/standing 2-6 hours