Director, Quality Assurance – Medical Device Services (Multi-Site)

Reporting directly to the President, Medical Device Services, the Senior Director, Quality & Laboratory Excellence is a strategic leadership role responsible for defining and executing the Quality vision across Eurofins Medical Device Services in North America.

This position is far more than a traditional Quality Assurance leadership role. We are seeking an executive leader who can build a modern, scalable, risk-based Quality organization that enables rapid business growth while maintaining the highest standards of scientific integrity, laboratory excellence, regulatory compliance, and customer confidence.

The successful candidate will lead the transformation and harmonization of Quality Management Systems across a growing network of laboratories and consulting businesses while supporting acquisitions, new service offerings, laboratory expansions, and future growth into medical device product development and engineering services.

Working closely with the President the leadership team, this individual will position Quality as a strategic competitive advantage that enables innovation, operational excellence, and commercial success.

Quality Leadership & Governance

Provide strategic leadership for Quality Assurance activities across multiple Medical Device Services sites.

Develop, implement, and maintain a harmonized Quality Management System (QMS) aligned with corporate and regulatory requirements.

Establish quality objectives, key performance indicators (KPIs), and continuous improvement initiatives across all sites.

Foster a culture of quality, compliance, accountability, and customer focus.

Lead Management Review processes and communicate quality performance metrics to executive leadership.

Ensure effective escalation and resolution of significant quality and compliance issues.

Regulatory & Quality Compliance

Ensure compliance with applicable regulatory, accreditation, and quality standards, including:

ISO/IEC 17025

OECD Good Laboratory Practice (GLP) and FDA 21 CFR Part 58

FDA 21 CFR Part 11

FDA Quality Management System Regulation (QMSR) / 21 CFR Part 820, as applicable

ISO 13485, as applicable

Medical Device Single Audit Program (MDSAP), where applicable

European Union Medical Device Regulation (EU MDR), where applicable

Other applicable national and international regulatory and accreditation requirements

Lead Quality Systems supporting ISO/IEC 17025-accredited laboratories and GLP-compliant operations while ensuring appropriate application of QMSR and ISO 13485 requirements where applicable.

Monitor changes in regulatory, accreditation, and industry standards and ensure timely implementation across all Medical Device Services sites.

Serve as the executive Quality representative during regulatory inspections, accreditation assessments, customer audits, and corporate Quality reviews.

Ensure timely and sustainable resolution of compliance observations, audit findings, and regulatory commitments through effective corrective and preventive action.

Quality Systems Oversight

Provide oversight and approval for Quality Systems elements such as:

Deviations and quality events

CAPA investigations

Change controls

Risk assessments

Internal audits

Supplier qualification and monitoring programs

Training and qualification systems

Document control processes

Ensure effectiveness of quality systems through trending, monitoring, and management review activities.

Drive standardization and harmonization of procedures across all sites.

Audit & Inspection Management

Lead preparation and execution of:

FDA inspections

ISO and accreditation audits

Customer audits

Corporate quality audits

Ensure audit readiness across all locations.

Oversee responses to observations and ensure sustainable corrective actions are implemented.

Monitor inspection trends and proactively address systemic quality risks.

Continuous Improvement & Operational Excellence

Champion continuous improvement initiatives utilizing Lean, Six Sigma, risk-based quality management, and operational excellence principles.

Drive quality metric reviews and identify opportunities for process optimization.

Promote data-driven decision making and quality risk management practices.

Support business expansion, new service offerings, and site integration activities from a quality perspective.

Leadership & People Management

Lead and develop site QA Managers, Supervisors, and quality professionals.

Establish talent development, succession planning, and performance management processes.

Ensure appropriate staffing levels and resource allocation across sites.

Mentor quality leaders and support employee engagement initiatives.

Promote collaboration among Quality, Operations, Regulatory Affairs, Technical, and Client Services teams.

Strong working knowledge of:

FDA 21 CFR Part 820

FDA 21 CFR Part 11

ISO 13485

ISO 17025

Medical Device Single Audit Program (MDSAP)

Risk Management principles (ISO 14971 preferred)

CAPA systems

Change Control systems

Internal Audit programs

Supplier Quality Management

Data Integrity requirements

Validation and Computer System Validation concepts

Statistical and trend analysis methodologies

Electronic Quality Management Systems (eQMS)

Education

Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, Medical Technology, Pharmaceutical Sciences, or related scientific discipline required.

Master's degree in Science, Engineering, Quality Systems, Regulatory Affairs, or Business Administration preferred.

Experience

Minimum 10–15 years of progressive experience in Quality Assurance, Regulatory Compliance, or Quality Systems within:

Medical Device Testing

Medical Device Manufacturing

Contract Research Organizations (CROs)

Contract Testing Laboratories

Healthcare or Life Sciences environments

Minimum 5 years of leadership experience managing Quality organizations.

Ability to travel up to 30–50% as required to support multiple domestic and international sites.

Demonstrated experience leading quality operations across multiple sites or business units.

Proven experience supporting FDA inspections, ISO audits, and customer audits.

Experience implementing and maintaining ISO 13485 and/or ISO 17025 compliant Quality Management Systems.

Eurofins offers a comprehensive benefits package including medical, dental, vision, life and disability insurance, 401(k) with company match, paid holidays, vacation, and opportunities for professional growth and development.

Eurofins USA Medical Devices is a Disabled and Veteran Equal Employment Opportunity employer.