Senior Quality Engineer Role:
We are seeking an experienced Senior Quality Engineer to join our dynamic team in Galway, Ireland.
The ideal candidate will have a strong background in quality management and engineering principles, with excellent communication and project planning skills.
Key Responsibilities:
* Support the development and maintenance of our Quality Management System
* Work closely with R&D, manufacturing, and regulatory teams to ensure compliance with user, regulatory, and ISO 13485 requirements
* Provide quality support during in-house manufacture and lot release
* Development of quality plans, programs, and procedures for commercialisation
* Ensure all work is carried out in compliance with Quality, Regulatory, and company policies and systems
* Review, analyse, and report on quality discrepancies related to product design and manufacture
* Liaise and support OEM contractors/vendors during the manufacture of components
* Support during regulatory agency audits including FDA and Notified Body and aid in the preparation of non-conformity responses, as necessary
Requirements:
* Bachelor's degree in a relevant Engineering or Science field
* 5 Years' experience in medical device industry or equivalent higher-level postgraduate study (masters or PhD)
* Project planning, communication, and writing skills
* Sound understanding of engineering fundamentals
* Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) essential
* Cleanroom and sterilisation experience preferred
* Process validation experience preferred
This is an exciting opportunity to contribute to the success of our company and advance your career in the medical device industry.