Quality Engineer
2 weeks ago
PE Global is currently recruiting for a Quality Engineer on behalf of a leading medical device company based in Sligo. This is an initial 18-month contract role.
Job Summary:
- To ensure that products manufactured at the site comply with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements.
- To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved. Ensure that all actions comply with current good manufacturing practice.
Responsibilities:
- 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.
- Where required, review batch records, ensuring documentation is compliant with requirements.
- Complete disposition decision for the batch.
- Participate in Risk Management activities as required.
Education and Experience:
- Degree in an Engineering, Science, Quality or other discipline.
- A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
- 4-6 years plus experience in the day-to-day operation of 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 an injection moulding or tooling environment is desirable.
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