SRG partner with a global medical technology company, providing discovery, diagnostics and delivery. They provide innovative solutions, leading in patient care, enabling medical research and supplying to laboratories.
To join their site in Berkshire, a Quality Engineer is required to support across QMS management, service and repair. Reporting to the principal QS Engineer, you will be responsible for post market surveillance activities, and developing the deployment of new quality processes.
- QMS support for the Service and Repair facility, including: managing change control, updating QMS documents, audit support, Management Review preparation
- Lead Repair-Related Complaint process driving investigations and providing feedback
- Conduct analyses of serviced products to identify root causes of failures
- Preparation of QMS Metric reporting and Post Market Surveillance (PMS) activities. Includes: PMS/PSUR Plans and Reports and Service support activities
- Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products
- Plan, develop and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, inspection method validations
- Quality support for regulatory and business tools supporting EUDAMED
- Lead and support ongoing Quality Improvement projects and initiatives
- Supporting the development and maintenance of supplier qualification activities for the Service organization
Skills and Experience
- Technical Degree in a related field of discipline, alongside experience in the medical device field
- Strong knowledge of worldwide applicable regulations for Quality Systems (EU MDR, ISO13485, 21CFR820)
- The ability to collect data, analyse situations and propose optimal process solutions to meet both Compliance and Business requirements
- A strong ability to prepare written technical plans and reports in support of PMS/PSUR, engineering changes, product or process validations, and failure investigations
- A working knowledge on managing life cycle documents and records and understanding of change control and training process requirements
- Knowledge of electro-mechanical medical devices (preferred).
- Experience in supplier/internal auditing would be an advantage.Ability to travel as required to support business activities.
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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