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Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Design Quality Engineer


Reference:JOM ATPB-468028 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance

JOM ATPB-468028

Design Quality Engineer

Full time, permanent position

Reporting to the Quality Manager

Job Summary:

We are looking for an experienced Design Quality Engineer with New Product Development experience.

  • The Design Quality Engineer will assure that new product designs and the processes for manufacturing meet all requirements in relation to safety and efficacy.
  • Represent quality interests and concerns on project teams.
  • Participates in Risk Management activities throughout product lifecycle
  • Perform quality activities (risk management, FMEA, creation of documents, document review) according to project schedule
  • Reviews design control compliance requirements for NPD projects and all design elements.
  • Heavy involvement in the development of DFMEAs, and supporting the development of PFMEAs.
  • Performs DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.
  • Participates in internal audit and supplier audit programmes.
  • Development of robust action plans, projects and verification activities for elimination of potential risks, as required
  • Working with cross-functional teams to effectively implement NPD projects
  • Familiarity with regulations including ISO 13485, 21 CFR 820, ISO 14971 and IVDR.
  • Provide advice and support to colleagues on quality matters
  • Represent quality department in company projects where required
Essential Criteria:
  • A minimum of a Bachelor’s degree (Hons) in Engineering, Technology, Science or related discipline. (Level 8).
  • Proven knowledge and experience (ideally minimum 5 years) of working with ISO13485, ISO14971, the IVD / IVDR: InVitro Diagnostics Regulation and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
  • Experience of FMEA, control plan development, Statistical Process Control (SPC) and capability analysis
  • Ability to manage competing priorities in a fast-paced environment
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels


Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role.


Contact Joan O’Malley at 087-1897333 for more details.