Quality Engineer
Fantastic new opportunity for a Quality Engineer to work as part of a well-established medical device manufacturing company in the Midlands. This is a full-time, 12-month contract position.
About the Role
* Support quality engineering activities related to the Quality Management System, product robustness changes, and compliance-related projects.
* Ensure technical correctness and compliance with global regulations.
The successful candidate will be responsible for:
Main Responsibilities
1. Coordinate QA resources to support Materials inspection and Operations.
2. Provide Operational QA Support for products and processes.
3. Conduct detailed root cause analysis and define corrective and preventive actions for Non-Conformance Reports (NCR).
4. Participate in continuous improvement activities to streamline processes.
5. Work with engineering teams to identify trends in failures, support root cause analysis, and implement corrective actions.
6. Conduct internal audits and lead KATA investigations towards root cause.
7. Develop Inspection plans for Incoming inspections, in-process, and Final QA inspection for products manufactured.
8. Detailed review and approval of Risk Management files.
9. Review and Approval of Change Orders associated with components and manufacturing processes.
Key Requirements
* Bachelor's Degree in Engineering/Science discipline with a minimum of 4 years working within a regulated industry.
* Excellent working knowledge of ISO 13485 and 21 CFR820 and MDSAP program, along with exposure to other regulations.
* Working familiarity with IEC 60601 is a distinct advantage.
* Experience in working within a CAPA program and other quality management systems.
* Experience with leading and participating in several projects concurrently.
* Experience in internal auditing to QSRs and ISO 13485 requirements.
* Strong problem-solving skills and attention to detail and accuracy are essential.
* Ability to work well under deadlines and pressure.