- Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
- Conduct detailed root cause analysis and define corrective and preventive actions for NCR
- Conduct Internal audits and Supplier audits against schedule
- Develop Inspection plans for Incoming inspections, Inprocess and Final QA inspection for products manufactured
- Detailed Review and approval of Risk Managements files
- Review and Approval of Change Orders associated with components and manufacturing process,
- Lead quality problem investigations using proven quality tools and providing training as necessary to staff with respect to problem resolution, process or procedure changes.
- 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.
- Ensure correct and timely disposition of MRB material.
- 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
- 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 to other Integra sites as part of duties.
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