**Fantastic New Opportunity for Quality Engineer**
This role is part of a well-established medical device manufacturing company in the Midlands, with a 12-month contract.
Key Responsibilities:
• Support quality engineering activities related to the Quality Management System, product robustness changes, and compliance projects.
• Ensure technical correctness and compliance with global regulations.
• Coordinate QA resources for materials inspection and operations.
• Provide operational QA support for products and processes.
• Conduct detailed root cause analysis and define corrective and preventive actions for NCRs.
• Participate in continuous improvement activities to streamline processes.
• Work with engineering teams to identify trends in failures and implement corrective actions.
• Conduct internal audits and lead KATA investigations.
• Develop inspection plans for incoming inspections, in-process, and final QA inspections.
Requirements:
• Bachelor's degree in Engineering/Science discipline.
• Minimum 4 years' experience in a regulated industry.
• Excellent knowledge of ISO 13485 and 21 CFR820, along with MDSAP program experience.
• Working familiarity with IEC 60601 is a distinct advantage.
• Experience in CAPA programs and other quality management systems.
• Strong problem-solving skills and attention to detail are essential.
• Ability to work under pressure and meet deadlines.
Desirable Skills:
IEC 60601, CAPA, Quality Assurance