Quality Assurance Engineer - Galway - Ireland
A worldwide designer, developer, manufacturer and marketer of medical devices used in interventional and diagnostic procedures is now looking for a Quality Assurance Engineer for their Galway operations centre.
*Provide quality support to assigned production departments ensuring product manufactured conforms to quality standards and specifications, GMP's of all medical device regulatory agencies.
*Preparation of daily/weekly/monthly metrics for areas of responsibility.
*Monitor and evaluate quality inspection procedures to ensure consistency, compliance and effectiveness, making recommendations for improvement and/or adjustment where needed to Technical Teams / Management for assigned Production Departments (Component, Sub Assembly & Finished Goods). Where appropriate implement approved changes.
*Performing of Internal and supplier quality audits and provision of support for internal and external regulatory audits.
*Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective / preventive actions to improve product quality.
*Providing guidance, direction to product line Quality Assurance Technicians and Auditors, Team Leaders / Supervisors on quality aspects of products relating to production departments assigned.
*Provide Quality Performance Information to members of Senior Management, Merit Galway.
*Review of document change orders to evaluate each change for quality related issues, initial product release documentation review.
*Completion of retrospective validation, prospective validation or revalidation of products / processes / tooling or methods as necessary.
*Quality representative on relevant Technical Team(s).
*Performs other related duties and tasks as required.
Summary of Minimum Qualifications:
*Degree in Quality Engineering or equivalent.
*Minimum of 3 years' experience in Quality environment, preferably in Healthcare/Medical Device industry.
*Knowledge of quality principles as defined in the regulations and the ability to utilize these methods in a manufacturing environment.
*Demonstrated computer skills preferably spreadsheets, word processing and other applicable software programs.
*Excellent communication and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.
*Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively.
*Ability to work as part of a team and meet targets/goals efficiently; take the lead in all quality related issues, set the pace/ standard for the teams that you are part of; ensure that work continues to flow at all times.
*Ability to work under strict time constraints and meet deadlines in a timely manner.
*Ability to read and understand complex manufacturing and production information, including production drawings, work orders, and related manufacturing and quality specifications.
*Demonstrate organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.
*Experience of applying Lean Six Sigma/8-Step problem solving techniques to improve business processes & performance is desirable.
A very attractive Salary/Benefits Package is on offer and negotiable
*Attractive Salary package
*Defined Contribution Pension Plan
*Health Insurance Cover
*Life assurance+ Health & Wellbeing Events Calendar + Excellent career progression opportunities+ Recognition scheme
*+ Free Parking
*+ Educational assistance
+ Internal training courses
*+ Quality Subsidised Canteens & Barista Service
*+ Active Sports and Social Club
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland