Senior Quality Engineer
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| Job Type | Contractor |
| Area | Sligo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2371 |
| Job Views | 85 |
- Description
Team Horizon currently has an exciting 12-month contract opening for a Senior Quality Engineer to work at our client’s manufacturing facility in Sligo. Working within the medical device operation you will support a number of NPIs to site.
Why you should apply:
•Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
•Continually improve the Quality Management System
•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 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 providing 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 Regulatory requirements.
•Assist in the performance of validation activities at the site.
•Ensure Quality System documentation is thorough, complete, and compliant.
•Ensure compliance to training requirements is maintained.
•Review lot records, ensuring documentation is compliant to requirements and completing lot release for shipment.
•Inspect incoming product 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 to requirements. Complete disposition decision for the batch.
•Participate in Risk Management activities as required.
What you need to apply:
•Degree in Science/Engineering/Quality
•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 a medical device environment is desirable.
