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Engineering & Technical

Job Description

A Quality Engineer is required by CareerWise Recruitment for our Cork based med device client. This is a 12 month initial contract role. Please contact Diarmuid Buckley for full details.

Role of this position

  • Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes.
  • Support Quality and Validation activities for product transfers and new product introductions.
  • Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
  • 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 conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ).
  • Develop pFMEA documentation to support processes as part of Validation process
  • 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 global functions and internal team on actions and deliverables.

JOB REQUIREMENTS

  • 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)
  • Ideally -experience working in both an FDA and European regulatory environment iwith an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
  • Understanding of GMP/ISO and validation regulations.

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Engineering & Technical

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie