Quality Assurance Engineer - Medical Devices - Galway - Ireland

14 days ago: Headhunt International

Job Description

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. Main Duties/Responsibilities: *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. REMUNERATION: A very attractive Salary/Benefits Package is on offer and negotiable Key Benefits *Fulltime contract *Relocation Expenses *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 APPLICATION: Please forward your CV immediately to: coh@headhuntinternational.com For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland www.headhuntinternational.com
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