Position:
Design Quality Engineer
Location:
Annacotty, Limerick

Serosep Limited are currently recruiting a Design Quality Engineer for a full time, permanent position here in Annacotty, Limerick.

 

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.

 

Main Duties:

  • Represent quality interests and concerns on project teams where required
  • 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

 

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: In Vitro 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

 

Closing date for applications is 7th October, 2022

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