Quality Engineer Level 1-Perm-Cork | Collins McNicholas

Quality Engineer Level 1-Perm-Cork

  • Reference: CJ44653y
  • Job Type: Permanent
  • Location: Cork, Cork City, Munster
  • Category: Engineering, Technical & Manufacturing

Due to continued expansion of our operations, we are seeking applications from a suitably qualified Quality Engineer.

Responsibilities:

  • Supervision of Quality Technicians.
  • Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
  • Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).

 

Educational Requirements:

  • Level 8 qualification required in Science or related discipline
  • Minimum of 2/3 years’ experience in a QA role.
  • Knowledge of GMP regulated environment and experience in a similar role would be an advantage.

 

For a confidential discussion and more information on the role, please contact Aisling Lane on 021 4809118 or email aisling.lane@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Aisling Lane

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