Quality Engineer
Job Type | Contractor |
Area | Mayo, IrelandRoscommon, IrelandSligo, IrelandLeitrim, Ireland |
Sector | Quality |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | 3375 |
Job Views | 134 |
- Description
Team Horizon is seeking a Quality Engineer on 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.
- Where required. 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:
- Degree in an Engineering, Science, Quality or other discipline
- Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
- 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.