Description
I am currently recruiting for a Quality Assurance Engineer with my client, a leading medical device company based in Galway. Engaging in the development, manufacture and distributionof proprietary disposable medical devices this is an excellent opportunity for a Quality Engineer to join this growing company.
Responsibilities:
- Lead and manage quality engineering support in assigned Production & R&D Departments
- Provide leadership to, and set/attain goals for, multi-functional project teams
- Take a lead role in quality systems and compliance and initiate, develop and implement improvements
- Provide guidance, direction and supervision to QA Technical Staff
Qualifications:
- Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher); Post graduate diploma/Masters in Quality Management desirable.
- Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), and JPAL/JGMP
- Good working knowledge of regulatory expectations and industry practices; Technical expertise in the review of technical files and design dossiers to ensure compliance to current standards
- Experience of applying Lean Six Sigma techniques to improve business processes & performance required
- Six (6)+ years' experience in a similar role / environment
- Proven track record of leading, motivating & developing technical staff
Candidates should also display excellent communication skills, passion for data, analysis, trends and reporting as well as possessing strong analytical skills and solution-driven thinking.
This role comes with a very competitive salary and benefits package on offer. If you are interested in this role please apply to this advert directly or contact me Derek Sheridan on for further information.
Sthree UK is acting as an Employment Agency in relation to this vacancy.