Primary Role

Oversees compliance for Medical Devices and Combination products to all applicable regulations including but not limited to: 21 CFR 4, 820, 803, GHTF, ISO13485 & 14971, MDD/MDR, IVDD/IVDR, MDSAP, etcEstablishes and maintains site and product certifications and provides global inspection leadership and submission supportEstablishes and/or improves cGMP processes for Device and Combination Products (DCP) quality management system (QMS)Establishes and maintains support for global product surveillance for medical devices, diagnostics, software devices, and combination productsInterfaces with and provides guidance on matters pertaining to Device Quality Assurance to cross functional stakeholders in the Device Center of Excellence and to other Quality organizationsAssesses product quality performance to demonstrate levels of control, capability, and compliance.

Responsibilities

40% Ensures functionality and maintenance of the certified DCP QMS in compliance with applicable regulations and standards.  Ensures that all processes needed for the QMS are maintained and inspection readiness is maintained.  Device specific processes include but are not limited to:

Device Master RecordsCustomer FeedbackTechnical Files / DossiersEstablishment and Product Registration / CertificationPost-Market Surveillance and Risk ManagementRegulatory IntelligenceDevice VigilanceMedical Device Labeling

30% Enables support for other global quality systems processes including but not limited to:

Management ReviewCustomer ComplaintsCAPADeviationsChange controlQuality Improvement PlansTrending and KPI MonitoringTraining

20% Participates in ongoing Quality initiatives, Integration support and Operational Excellence

10% Influences QMS strategy to enhance and execute sustainable Device Quality support for internal and external manufacturing, packaging, testing and release of device and combination products

Education & Experience Requirements

Essential:  

Bachelor’s Degree in Engineering, Natural Science and/or Medical Degree or equivalent technical discipline requiredAt least 10 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 5 years in Quality Assurance/EngineeringKnowledge of international regulations for Device and Combination Products particularly Medical Device Directive 93/42/EEC, US 21 CFR Part 4, 820, 803, ISO 13485 and ISO 14971, MDD/IVD, MDSAP, and MDR/IVDRExperience with Class I & II & III sterile and non-sterile medical devices and implantable devicesExperience interacting and collaborating with cross-functional global teamsExperience working with external manufacturing partnersStrong operations background to ensure value added and effective quality operations

Desired:  

Advanced Degree;Experience working in a post-market quality support function preferredKnowledge of in-vitro diagnosticsExperience assessing root cause analysis and effective investigation practicesExtensive experience in trend analysis and statistical techniquesUnderstanding of GDPs and global supply and distribution networks

Other Requirements

Domestic and international travel up to 25% for business meetings with local staff, corporate peers/collaborators, Device Supplier Audits, Contract Manufacturing Operators and to stay current with professional development opportunities.