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Engineering & Technical

Job Description

A Technology Transfer Quality Engineer is required by CareerWise Recruitment for a major global med device client to lead the QA function of process / technology improvements and product transfers . This is an initial 12 month contract role . Please contact Diarmuid Buckley for full details.

Role of this position

  • Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products.
  • Document and maintain in good order all relevant Quality assurance sections of Device Development History File and DMR as directed by Data Management.
  • Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
  • Provide QA input for URS for new technology / equipment.
  • Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
  • Lead Design for Inspection activities for all NPD to ensure latest technology is available to reduce Human factor.
  • Lead QA input in Design for Manufacture activities on site.
  • Ensure correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
  • Ensure compliance with all Documented Quality system, as per SEP 180 i.e. FDA QSR's and ISO 13485/9001 requirements etc. during day to day and assigned audit/CAPA activities
  • Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
  • Assist in problem solving in established production process enabling reduction in scrap and reprocessing.

JOB REQUIREMENTS

  • Degree level or similar qualification in mechanical or industrial engineering.
  • 3- 5 years' experience in a quality role within a regulated industry.
  • Proven ability to successfully introduce new product development in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
  • Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
  • Proven experience and training in Mechanical Engineering processes.

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) 21 206 190

Email: info@careerwise.ie