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Senior Quality Engineer

Job description

About Your New Employer

  • One of the most well-known corporations in the medical device industry.
  • There are several prospects for advancement and development.
  • More than 6,000 people are employed at its sites, making it Ireland's largest life sciences employer.

About Your New Job

  • As a Senior Quality Engineer, you will be supervising Quality Engineers and Quality Technicians.
  • You will drive and execute process improvements across all product lines to ensure predictable processes (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • You will provide effective and responsive QA support to Operations.
  • Ascertain that all process variables, as well as their interactions, are well specified.
  • Ascertain that all process failure modes have been recognized and addressed (for example, DOE studies and FMEAs).
  • Drive and implement changes to the plant's quality system.
  • Ensure regulatory compliance with cGMPs of all medical device regulatory agencies in your area of responsibility (e.g. FDA and TUV).
  • Identifying and implementing relevant statistical tools for monitoring process performance is essential (e.g. SPC, CpK analysis, sampling techniques).
  • Approval of analytical reports and trend analysis of customer complaints.
  • Validation: Define process and product validation needs, prepare and approve Master Validation Plans, and approve protocols and reports.
  • Compilation of all necessary regulatory documents (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
  • MRB: Review of MRB trends and, if necessary, determination of relevant corrective steps.
  • Conduct internal quality assurance audits.
  • Assist with the deployment of Lean Manufacturing throughout the facility.
  • Product and methods should be transferred and implemented from development or another manufacturing plant.

What Skills You Need

  • A suitable Engineering / Science degree with a minimum level 8 qualification is required.
  • Ability to operate effectively as part of a team and fulfill targets/goals.
  • Excellent problem-solving and analytical abilities.
  • Decision-making abilities have been demonstrated.
  • Experience in a manufacturing environment of at least 4 years is required.
  • Strong experience in people management.
  • Solid understanding of quality principles and the ability to apply them in a production setting.

What’s on Offer

  • Competitive basic salary of up to EUR 65,000 per annum, along with an annual bonus and attractive benefits package
  • Relocation assistance if required
  • Lots of upskilling opportunities - an excellent leadership program

What’s Next​

  • Apply now by clicking the “Apply Now" button or call me, Barbara Szatkowska on +353 86 796 1534 or if the job isn’t quite right but you are looking for something similar, please get in touch!

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