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Quality Engineer (Operations)

Quality Engineer (Operations)

Job description

About Your New Employer

You will work for a medical device packaging company based in Mullingar, Co. Westmeath on a permanent basis.  This is a new job that has opened due to expansion within their quality department. This is a small start-up company who have been acquired by a global company with styles in the US, China, and Asia.

About Your New Job   

As a Quality Engineer you will…

  • Lead quality improvement programmes using recognised problem-solving and project management techniques.
  • Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated, and corrective and preventive actions are closed in a timely and effective manner. Customer onboarding process is a key element of the position.
  • Management of customer documents into the Quality system i.e., Drawings; Purchase
  • Specification; Quality Agreements etc. and the training of relevant personnel.
  • Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
  • Adhere to incoming control requirements and supporting the SCAR process when required.
  • Participate in the review of validation protocols and reports to ensure quality compliance.
  • Execute internal process and system audits.
  • Manage quality projects in support of continuous improvement e.g., Lean Projects.
  • Co-ordinate activities associated with change management and customer interaction.
  • Ensure the timely and effective closure of day-to-day quality issues.

What Skills You Need

  • Honours Bachelor’s Degree in an Engineering or related field
  • Minimum of 2 years’ experience in a quality engineering role in a medical device company
  • A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage.
  • Ideally understand sterile sealing manufacturing process.

What’s on Offer

  • Competitive Salary
  • 10% Bonus
  • Healthcare
  • Pension Contribution up to 6%

What’s Next

Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.