A key role of this position is to proactively support quality engineering activities with regards to the Quality Management System, product robustness changes 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- 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
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.