A global medical technology company is recruiting a Quality Manager – Risk Management for their facility in Winnersh. You will provide leadership of the Risk Management Function for medical products. Through adequate communication, effective problem solving and active vigilance on applicable requirements, you will be accountable for the compliance of risk management activities related to new product introduction (NPI) and product maintenance. You will also drive compliance and continuous improvement of risk management processes with the support of the Quality Engineering function.
As Quality Manager – Risk Management, you will;
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 enhancements.
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 proper application, use and updates of risk management files.
Work with Clinical personnel on creation of appropriate harm/hazard analysis for issues potentially impacting patient outcomes.
Keep up to date on new regulations and standards that affect Risk Management for medical devices. Ensure Risk Management procedures, processes and files are updated where required.
Train and develop Quality engineers to provide efficient support for execution of risk management activities in a harmonized manner as well as key stakeholders to improve the overall risk management process efficiency.
Implement appropriate tools to manage the activity (IT tools, risk management tools).
The successful candidate will have an Engineering degree in a technical field with relevant experience in the medical device industry. You will have strong knowledge of Risk Management discipline and must be able to apply quality principles to the R&D environment.
You will also have the following attributes:
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, Rigor and good organization, pragmatic.
The ability to make timely critical decisions regarding product risks and compliance.
The capacity to engage and deliver on objectives and expectations. Proven track record of initiating and driving continuous improvements.
Must have proven leadership, communication, organization and project management skills.
The ability to communicate efficiently to leadership team, internal customers and key stakeholders and influence.
Keywords: quality, risk, NPI, 14971, CAPA
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