Quality Engineer

2 weeks ago

Sligo, Sligo, Ireland TEAM HORIZON Full time

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Team Horizon is seeking a Quality Engineer for an 18 Month contract on behalf of our client, a leading medical device manufacturer in the Connaught region.

Why you should apply:

  • Opportunity to work as a member of a diverse Quality Team to ensure that Quality goals and objectives are achieved

What you will be doing:

  • Coordinating appropriate 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.

What you need to apply:

  • 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 (ISO/ISO; CFR 21 Part ) 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.
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