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Senior Quality Assurance Engineer
We are proud to be working with a successful medical device company in Ireland; they are growing as a company and require a Senior Quality Engineer to support the Quality Manager in ensuring that all product released for human use meets the Company’s product quality requirements, and to ensure that product is manufactured, released and distributed in accordance with regulatory requirements.
The successful candidate will support the finished device manufacturing subcontractor and stent supplier to ensure that product quality and regulatory requirements are met. Perform lot review and lot release activities. Support the operations group to ensure that product manufacture and release activities meet business needs. Review and contribute to process validation and risk management activities of the subcontractor and stent supplier. Support Operations, subcontractors and suppliers in implementing process improvement and lean initiatives. Ensure that SCAR’s, CAPAs, NC’s and other open action items, are completed in a thorough and timely manner. Assess and process supplier and company changes, ensuring product impact is appropriately considered. Plan, execute, report and follow-up on subcontractor and supplier audits. Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
- A minimum of 5 years’ manufacturing quality experience is required, of which at least 2 years should be in a Medical Device manufacturing environment.
- Experience of managing relationships with subcontractors and suppliers is preferred.
- Experience in performing process validation and risk management activities is required.
- Excellent attention to detail, communication skills, project management skills, people and team working skills.
- Excellent problem-solving skills
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