My client is a global provider of pen needles for the care of Diabetes patients worldwide. They have various sites throughout Ireland including two R&D sites in Limerick and two large scale manufacturing sites in Dublin and Wexford. This site in question, based in Enniscorthy, runs 24/7 and develops and manufactures medical devices used by interventional cardiologists, radiologists, and vascular surgeons in angioplasty procedures. Their products are used to clear blockages in two distinct areas of the vascular system: coronary arteries and peripheral arteries.
I am looking for a talented Quality Engineer with New Product Development experience for their state-of-the-art facility in Enniscorthy.
Reporting directly to the Quality Manager, some of your responsibilities will include:
- Assuring that new product designs and the processes for manufacturing them meet all local, corporate and divisional requirements with respect to safety and efficacy
- Leading the Quality engineering activities for NPD projects
- Developing design and process risk management documentation with cross-functional support
- Supporting the development of device Design Inputs, Design Outputs, Product Specifications, and applicable design control documents
To be successful in this position you should have the following experience:
- Educated to degree level Engineering/Technical/Science
- A minimum of 5 years in the medical device or pharmaceutical industry
- A familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR
- Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines coupled together with problem solving techniques with excellent organisational skills
To learn more about this role apply online or call Helena Boyle on + 353 1 6321870 or +353 873360953 for a confidential discussion.