We are a market leading Medical Device Manufacturer and due to our exceptional continued growth, we have an exciting opportunity for a Quality Manager – Risk Management to join our team.
As our new Quality Manager – Risk Management, you will be the subject matter expert for all things Risk Management within Medical Devices. You will provide leadership of the Risk Management Function for infusion products. Through excellent communication, effective problem solving and active vigilance on applicable requirements, you will lead compliance of risk management activities related to new product introduction (NPI) and to product maintenance for the infusion pump product. You will also drive compliance and continuous improvement of risk management processes with the support of the Quality Engineering function.
- Provide Risk Management technical expertise through the product life cycle (act as an SME in RM)
- Develop or remediate and maintain Risk Management Files according to ISO 14971 and MDR requirement
- Work with R&D and Sustained Engineering on the development and incorporation of Risk Management and compliance to standards during all design phases for new and/or product improvements.
- Facilitate development and completion of risk assessments for field issues/complaints in the field.
- Work with all production and post-production functions (manufacturing, post market surveillance, complaints, CAPA, Corrections and Removals, Change Control, Supplier Quality, acceptance activities) to ensure the accurate application, use and updates of risk management files.
Experience, skills and/or knowledge required:
- Proven experience and knowledge of Risk Management (ISO 14971) within the context of Medical Devices.
- In depth experience of working within Quality Assurance/Regulatory Affairs/Compliance within the Medical Device Sector.
- Demonstrate knowledge of risk management, regulatory and quality engineering policies, principles and best practices for medical devices
- Good understanding of Medical devices design and development requirements
- Strong analytical, technical and problem-solving skills, Rigour and good organisation, pragmatic
If you have the skills and experience required to be successful in this role, please apply now or contact Kris Holmes on 01189 239 234.
Permanent, Full Time
- Industry Sector Engineering, Utilities
Manager (Manager/Supervisor of Staff)