Excellent opportunity for a motivated and flexible self-starter with strong leadership skills
Quality Engineer (Complaints)- Pharmaceuticals/ Medical device- North Dublin
This role is an excellent opportunity for a motivated and flexible self-starter with strong leadership skills with both quality systems and manufacturing experience. The candidate will have experience in the medical device or pharmaceutical industry. Experience in both industries would be advantageous.
- Subject matter expert on site to lead investigations both internally and externally and drive/implement solutions in a timely manner
- Lead complaints laboratory to support customer complaints for products manufactured at the site
- Risk management with implementation of risk mitigation activities with continuous review/trending of component performance on the manufacturing lines
- Design, write and approve technical protocols to support investigations partnering with manufacturing, engineering and the device group internally and vendors externally to co-ordinate line trials including troubleshooting activities
- Conduct regular vendor visits to new and existing suppliers to become subject matter expert on vendor processes to support technical investigations and assessment of any proposed changes
Education and Experience:
- The ideal candidate will be a Mechanical/Chemical/Quality Engineering graduate. Post graduate qualification an advantage
- 5-10 year's experience in a similar role within the Pharma/Medical Device or related industries
- Experience of Dry Powder Inhalers, powder handing, component moulding and assembly would be advantageous
- A working understanding of appropriate regulatory requirements, including 21 CFR Parts 210/211, ISPE/ICH Guidelines (including QbD enhanced approach) and EudraLex./preferred
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.