Job DescriptionQuality 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 RequirementsStrong 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)
QualificationsEducation
- 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.
Additional InformationEurofins 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.
