Director, Quality Assurance – Medical Device Services (Multi-Site)
Eurofins · Maryland Heights, MO, United States · Posted Jul 9, 2026
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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.
Technical Knowledge Requirements
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.
Expe…