Quality Assurance Engineer II – Operations

  • Reference: GJ46922
  • Job Type: Permanent
  • Location: Connacht, Galway, Galway City
  • Category: Medical Devices

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 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.
  • 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

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