Senior Quality Assurance Manager
Confidential Executive Search
A 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 Overview
* Overall responsibility for Quality at the Irish site and associated contract manufacturers
* Leadership of the site Quality Management System in compliance with FDA QSR, ISO 13485:2016, and EU MDR
* Senior Quality oversight for contract manufacturing, including governance, performance monitoring, and finished goods release
* Quality leadership for Ireland-based design, development, and new product introduction activities
* Act as Management Representative, leading regulatory inspections and ensuring ongoing audit readiness
* Oversight of post-market surveillance, vigilance, complaints, supplier quality, and sterilization partners
* Strategic partnership with Manufacturing, R&D, and Regulatory functions
* Leadership, development, and succession planning for the Quality organization
Candidate Profile
* Degree-qualified in Engineering or Life Sciences (Master's preferred)
* 15+ years' experience in medical devices or other FDA-regulated industries
* 10+ years' experience in senior Quality or Regulatory leadership roles
* Deep expertise in FDA QSR, ISO 13485, and EU MDR
* Proven track record leading FDA and global regulatory inspections
* Strong executive presence with the ability to influence at senior and global levels
Why This Role
This 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.