Quality Engineer

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 (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.