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

Company Description

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.

In addition to leading Quality for Medical Device Services, the Senior Director will serve as an active member of the North America Quality Leadership Team, collaborating with Quality leaders across the BioPharma Product Testing (BPT) and Medical Device Services (MDS) businesses to advance enterprise-wide Quality initiatives, share best practices, harmonize Quality systems where appropriate, and strengthen a consistent culture of Quality across laboratories and business segments while recognizing the unique regulatory requirements of each market.

Job Description

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 initi