- Reference: AJ45662
- Job Type: Permanent
- Location: Offaly, Westmeath
- Category: Engineering, Technical & Manufacturing
Key role of this position is to support quality engineering activities with regards to the Quality Management System, specifically Supplier Management and compliance related projects ensuring compliance with requirements of global regulations.
Under direct supervision of the QA Manager
- Maintain oversight of current suppliers and assess potential new suppliers and service providers for technical, quality, and quality system capabilities.
- Implement continuous and innovative improvements
- Drive the supplier audit program.
- Evaluate nonconforming supplied material and prepared Supplier Correction Action Requests to effective resolution of root cause problems contributing to unsatisfactory supplier quality performance.
- Liaise with Operations, Supply Chain Management, Warehouse, Engineering and PD to ensure uninterrupted supply of materials.
- Support NPIs by providing guidance on compliant adherence to company requirements as defined in material specifications, CTQ’s, process control plans, quality agreements and other defined requirements.
- Provide Operational QA Support for products and process.
- Degree in Quality, Engineering or a Science discipline.
- 3-5 years’ experience at quality engineering level within a regulated industry, preferably the Medical Device Industry
- Demonstrable knowledge of FDA 21CFR820 and/or ISO 13485 regulations
- Audit experience in conduction supplier and or internal audits
- Certified Lead auditor qualification for 13485 is an advantage.
- Knowledge in statistical methods
- Familiarity with use of ISO 14971:2007 an advantage.
- Willingness to travel as part of duties.
For more information or to apply please contact Tina Egan on email@example.com 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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