Technical & Engineering JobsQuality Engineer

  • CJ49811
  • Temporary/Contract
  • Cork, Cork City

Collins McNicholas

Role Responsibilities:

  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • 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.
  • Provide functional expertise to other support functions on quality related issues.
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Review, assessment and approval of change notices for product, process and quality system changes.
  • Customer complaints: analysis of complaint trends.
  • Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Perform internal quality audits.
  • Support the implementation of Lean Manufacturing across the site.
  • Transfer and implement product and processes from development or from another manufacturing facility and support introduction of new products.

 

Role Requirements:

  • Minimum of Bachelor of Science Degree in Engineering/Technology
  • 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
  • Experience in the medical device industry is an advantage.

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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