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Quality Engineer

  1. East
County Sligo
  1. Contract
Competitive
  1. Compliance / Quality Assurance
15-04-2024
33888QE/WP
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Quality Engineer - Medical Device - Sligo, Ireland - 6-Month Contract 

Pharmaceutical plant manufacturing medical device /combination products have a contract requirement for an experienced Quality Engineer. Working within the Quality team  you will ensure that all products manufactured at the site comply with approved regulatory and GMP requirements.


Responsibilities will include:
  • Coordinate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
  • Audit the quality system with other personnel where required.
  • Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.
  • Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
  • Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc.
  • Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
  • Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
  • Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.
  • Ensure implementation and compliance with relevant Regulator requirements.
  • Assist in the performance of validation activities at the site.
  • Ensure Quality System documentation is thorough, complete, and compliant.
  • Ensure compliance with training requirements is maintained.
  • Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment.
  • Inspect incoming products and manage the supplier Quality relationship.
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
  • Complete in-process and final release product testing per the relevant approved specifications and procedures.
  • Review batch records, ensuring documentation is compliant with requirements.
  • Complete disposition decision for the batch.
  • Participate in Risk Management activities as required.

Essential Requirements
  • Degree in an Engineering, Science, Quality or other 
  • A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
  • 2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
  • Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.
  • Experience in an injection moulding or tooling environment is desirable.

Apply now to discuss this role in furhter detail!

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