Quality Assurance Engineer

Description

My client, a global medical device company, is currently recruiting a Quality Assurance Engineer to join their team in Galway. The successful candidate will lead and manage quality engineering support in assigned Production and R&D Departments and provide leadership to, set and attain goals for, multi-functional project teams

Responsibilities and Skills:
- Take a lead role in quality systems and compliance and initiate, develop and implement improvements
- Provide guidance, direction and supervision to QA Technical Staff
- 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.
- Proven track record of leading, motivating & developing technical staff
- 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
- 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.
- 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.
- Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process.
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.

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.
- Six (6)+ years' experience in a similar role / environment
- 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
- Experience of applying Lean Six Sigma techniques to improve business processes & performance required

If you feel you are a good fit for this role please apply directly to this advert or contact Derek Sheridan on for further detail.

Sthree UK is acting as an Employment Agency in relation to this vacancy.