Description
I have an immediate opening for a Quality Assurance Engineer with my client, a leading medical device company specialising in the development, manufacture and distribution of proprietary disposable medical devices, based in Galway.They are looking for an experienced Quality Engineer to join their operations team who has good experience design controls & processes, good statistical knowledge, good knowledge of test method validation and a working knowledge within ISO14971.
The ideal candidate will:
- 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
Qualification/Experiences:
- 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
Candidate should also have:
- Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.
- Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively.
- Possesses strong analytical skills and solution-driven thinking; collects and researches data; uses intuition and experience to complement data. Makes good decisions based upon a mixture of analysis, wisdom, experience and judgment.
If you feel you are a good fit for this role and are interested in hearing more please apply directly to this advert or call Derek Sheridan on for further information