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Quality Engineer

  • Location:

    Cork

  • Contact email:

    jsimilak@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +353214315770

  • Job type:

    Full Time

  • Job ref:

    JSiQEBS2708

  • Salary:

    €40,000 - 50,000

  • Published:

    25 days ago

  • Contact email:

    jsimilak@sigmar.ie

Job description

Are you an experienced Quality Engineer ready to join a medical devices leader that changes lives?

Job Purpose:
Act as a member of the  Cork facility Quality Team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.

Job Responsibilities:

  • Supervision of Quality Technicians.
  • Drive and implement process and quality system improvements.
  • Provide effective and responsive QA support to Operations.
  • Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
  • Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation.
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Perform internal quality audits.
  • Support the implementation of Lean Manufacturing across the site.
  • Transfer and implement product and processes from development or from another manufacturing facility.


Job Requirements:

  • Minimum of Bachelor of Science Degree in Engineering/Technology
  • 2+ years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
  • Experience in the medical device industry is an advantage.

For a confidential discussion please reach out to Jakub on 021 2359 140 or jsimilak@sigmar.ie

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