Description:
PE Global is recruiting a Quality Engineer for a leading medical device company in Sligo. This is an initial 18-month contract role.
Job Summary:
* To ensure manufactured products comply with approved specifications and current good manufacturing practice and Regulatory Agency requirements.
* To work as part of the Quality Team to achieve Quality goals and objectives, ensuring all actions comply with current good manufacturing practice.
Responsibilities:
* Coordinating assigned elements of the Quality System, ensuring full compliance by plant personnel with its requirements.
* Auditing the quality system with other personnel where required.
* Assisting in the investigation and coordination of customer complaints and assessing the need for implementation of effective corrective or preventive actions.
* Managing day-to-day CAPA requirements, ensuring timely and effective initiation, investigation, correction, and corrective actions.
* Measuring performance of the Quality System and providing metrics for inclusion in management reviews, monthly reports, etc.
* Ensuring plant personnel are aware of quality requirements by providing necessary training.
* Informing Management of system failures to ensure corrective/preventive action and product containment, if necessary.
* Verifying effectiveness of corrective/preventive actions arising from product process and quality system non-compliance.
* Ensuring implementation and compliance with relevant Regulator requirements.
* Assisting in validation activities at the site.
* Ensuring Quality System documentation is thorough, complete, and compliant.
* Maintaining compliance with training requirements.
* Reviewing lot records, ensuring documentation is compliant with requirements, and completing lot release for shipment.
* Inspecting incoming products and managing supplier Quality relationships.
* Participating in continuous improvement programs to implement improvements in quality, safety, environmental, and production systems at the site.
* Completing in-process and final release product testing per relevant approved specifications and procedures.
* Reviewing batch records, ensuring documentation is compliant with requirements, and completing disposition decisions for batches.
* Participating in Risk Management activities, if required.
Education and Experience:
* Degree in an Engineering, Science, Quality, or other discipline.
* Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
* 4-6 years plus experience in operating the quality system in a highly regulated combination product/device manufacturing environment.
* Minimum 4-6 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 injection moulding or tooling environments is desirable.