QUALITY ENGINEER (MED. DEV)WESTMEATH

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  • Job reference number:15321141
  • Client ID:RI/BBBH657
  • Posted on:08-FEB-2018
  • Salary:NEGOTIABLE
  • Location:WESTMEATH, WESTMEATH
  • Job type:CONTRACT

Benefits: CAR PARKING

SUMMARY DESCRIPTION

Key role of this position is to proactively support quality engineering activities with regards to the Quality Management System, product robustness changes & compliance related projects, ensuring technical correctness, & compliance with requirements of global regulations.

This company is transferring a product from Ireland to the USA & they need someone to work on the QA s ide of this with the team

Under direct supervision of the QA Manager you will: -

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

  • Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) & for change on existing products, conduct design verification & validation studies, review & approve protocols, studies, & perform general oversight responsibilities for validation process, for both equipment & processes.
  • Conduct detailed root cause analysis AN define corrective & preventive actions for NCR
  • Conduct Internal audit s & Supplier audit s against schedule
  • Develop Inspect ion plans for Incoming inspect ions, Inprocess & Final QA inspect ion for products manufactured
  • Detailed Review & approval of Risk Managements files
  • Review & Approval of Change Orders associated with components & manufacturing process,
  • Lead quality problem investigations using proven quality tools & providing training as necessary to staff with respect to problem resolution, process or procedure changes.
  • Ensure that requirements laid down in the quality manual & standard operating procedures are adhered too, & provide advice & guidance to other departments on quality related aspects.
  • Provide Operational QA Support for products & process.
QUALIFICATIONS/EXPERIENCE

  • Degree in Quality , Engineering or a Science discipline.
  • 3-5 years' experience at quality engineering level within a regulated industry, preferably the Medical Device Industry
  • Demonstrable knowledge of FDA 21CFR820 &/or ISO 13485 regulations
  • Familiarity with use of ISO 14971:2007 an advantage.
  • Ability to communicate effectively with management & fellow peers, both orally & in reports
PERSONAL COMPETENCIES

Good project planning & organizational abilities.

  • Strong interpersonal & communications skills, including oral & written reports.
  • Pro-active with proven ability to work under own initiative, & strong team player.
  • Solid technical ability.
  • Willingness to travel to other sites as part of duties.
Please apply to the role and then we can discuss in detail

This job originally appeared on RecruitIreland.com