Engineering & Electronics

Quality Engineer

  • Contract
  • Remote
  • Munster
  • 41950132

The role:
PE Global is currently recruiting for a Quality Engineer on behalf of our client based in Cork. This is a 12 month initial contract

Responsibilities:

  • Support Quality and Validation activities for product transfers and new product introductions.
  • Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
  • Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
  • Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis)
  • Determine process inputs and factors for variation where process capability is required.
    Responsible for reviewing Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
  • Responsible for conducting Test Method Validations as required
  • Develop/Review pFMEA documentation to support processes as part of Validation process
  • Partner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
  • Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
  • Support root cause analysis activities related to material processes.
  • Communicate effectively with internal team on actions and deliverables.
  • Provide timely and accurate reporting and management of escalations as appropriate on project activities.
  • Ensure all activities comply with GMP, ISO and quality system requirements.
  • Ensure that all health, safety and environmental requirements are fulfilled.

Education and Experience:

  • BSc in Engineering or Science with 2 years experience in a medium to high volume manufacturing environment
  • 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
  • Problem solving engineering expertise (Six Sigma, SE or A3)
  •  Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • A thorough understanding of GMP/ISO and validation regulations.

Interested candidates should submit an updated CV.

Please click the link below to apply, call William on 0214297900 or alternatively send an up to date CV to william.cunnage@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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