Quality Assurance Engineer (Operations) - Galway
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 and output.
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, Galway Site.
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
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland