Senior Supplier Quality Engineer
Posted on Feb 9, 2021 by Real Staffing Group
Job title: Senior Supplier Quality Engineer
Location: Brand new site in Parkmore, Galway
Benefits: Excellent salary, pension, healthcare, yearly bonus and an opportunity to grow in an exciting Medical Device company.
This is a highly collaborative position working closely with R&D, Operations and key suppliers to ensure the effective supply of high-quality finished product for development projects, clinical and commercial activities. Your role will be to support the Quality Manager in ensuring that product is manufactured, released and distributed in accordance with the relevant quality and regulatory requirements
- Support the finished device manufacturing subcontractor and stent supplier to ensure that the 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.
- Provide manufacturing QA support to process and product development projects.
- 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 changes, ensuring product impact is appropriately considered.
- Provide QA support for post product release supply chain activities.
- A minimum of 5 years' relevant experience in the medical device industry, of which at least 4 years should be in a manufacturing quality role.
- Experience of managing relationships with subcontractors and suppliers is preferred.
- Experience in Class III medical device requirements, ISO 13485; 21 CFR 820; and MDD/MDR as well as Quality Management Systems.
- CAPA, Auditing and Risk Management experience per ISO 14971 (including FMECA).
Would you be interested in discussing this opportunity? Forward your up to date CV and we can organise a time for a call to go through in detail.
Look forward to hearing from you.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales