Senior Quality Assurance ManagerConfidential Executive SearchA global medical device organization is seeking an Senior Manager/Associate Director of Quality to provide senior Quality leadership for its Irish quality operations, distribution and external contract manufacturers across EMEA. This role carries broad responsibility for Quality strategy, regulatory compliance, and oversight of both internal and outsourced manufacturing activities.Reporting into senior global Quality leadership, the successful candidate will play a critical role in ensuring patient safety, regulatory compliance, and operational excellence across EMEA.Role OverviewOverall responsibility for Quality at the Irish site and associated contract manufacturersLeadership of the site Quality Management System in compliance with FDA QSR, ISO 13485:2016, and EU MDRSenior Quality oversight for contract manufacturing, including governance, performance monitoring, and finished goods releaseQuality leadership for Ireland-based design, development, and new product introduction activitiesAct as Management Representative, leading regulatory inspections and ensuring ongoing audit readinessOversight of post-market surveillance, vigilance, complaints, supplier quality, and sterilization partnersStrategic partnership with Manufacturing, R&D, and Regulatory functionsLeadership, development, and succession planning for the Quality organizationCandidate ProfileDegree-qualified in Engineering or Life Sciences (Master's preferred)15+ years' experience in medical devices or other FDA-regulated industries10+ years' experience in senior Quality or Regulatory leadership rolesDeep expertise in FDA QSR, ISO 13485, and EU MDRProven track record leading FDA and global regulatory inspectionsStrong executive presence with the ability to influence at senior and global levelsWhy This RoleThis is a rare opportunity to step into a high-impact, confidential leadership position within a globally regulated medical device organization, offering significant scope to shape Quality strategy across Ireland and external manufacturing partners.