Senior Quality System Engineer (Galway)

Job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details: About the Role / Job Description We are looking for a Senior Quality Systems Engineer to join our team in Galway, supporting a growing medical device business as it transitions from a start-up environment into a scaled, high-volume operation. This is a hands-on role where you will take ownership of the site Quality Management System , ensuring it remains compliant, effective, and fit for purpose. In parallel, you will play a key role in the integration of a global QMS following acquisition , helping to align ways of working while maintaining the agility and strengths of the existing site. You’ll work closely with both local teams and global stakeholders, with real opportunity to influence how quality systems evolve on site. Essential Duties: - Ownership of the site QMS , ensuring ongoing compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR - Lead and support core QMS processes including: - CAPA - Change Control - Nonconformance Management - Docu...