- Key role of this position is to proactively support quality engineering activities with regards to the Quality Management System specifically Supplier Management and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of continuity and improvement of the established QMS, delivered product quality and to support growth of the Company.
- 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.
- Ability to communicate effectively with management and fellow peers, both orally and in reports
- Good project planning and organizational abilities.
- Strong interpersonal and communications skills, including oral and written reports.
- Pro-active with proven ability to work under own initiative, and strong team player.
- Solid technical ability.
- Willingness to travel as part of duties.
- 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 with demonstrated and measurable results – e.g. Dock to Stock Program, Cost of Poor Quality
- Drive the supplier audit program through managing and conducting supplier audits per schedule. Ensure proper root cause is determined and implemented by the supplier when there is a finding.
- Evaluate nonconforming supplied material and prepared Supplier Correction Action Requests (SCAR) to effective resolution of root cause problems contributing to unsatisfactory supplier quality performance.
- Ensure supplier files are compliant with regulations and internal procedures.
- Partner with Site purchasing & integrate Division Supplier Quality team to leverage cross site competencies and drive improvements.
- 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.
- Ensure that requirements laid down in the quality manual and standard operating procedures are adhered too, and provide advice and guidance to other departments on quality related aspects.
- Provide Operational QA Support for products and process.
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