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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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