Description
I have an immediate opening for a Quality Assurance Engineer with one of the leading medical device companies based in Galway (Salary €45K-€55K). This is is an excellent opportunity to join a fantastic company who are embarking on major expansion. Working in a friendly family-feel environment this is a great company to work with that offers candidates excellent training and opportunities for career progression.Working with the Diagnostics department this role requires a strong character who will be a team leader. Experience in Statistics and validation are highly desired but not essential.
Successful candidate will:
* 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/ 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 the following abilities/skills/qualities:
* 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.
* 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.
* Demonstrates organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.
This really is a great opportunity to join a company with an excellent reputation within the industry. If you are interested in this opportunity please apply directly to this advert or contact Derek Sheridan on