Quality Assurance Manager - IVD and Medical Device
- Innovative Medical Technology company, conducting cutting edge research
- Unique opportunity to work with both Medical Device and IVD products
- Cambridge based role. Competitive salary package.
SRG partner with a leading medical technology company, who stand at the forefront of innovation in the gastroenterology field. Due to continual business growth, a Quality Assurance Manager is required to join their team in Cambridge.
You will be responsible for developing and maintaining a comprehensive quality management system. You will act as Quality Assurance support for R&D, manufacturing and validation activities. The position will also encompass QA and RA input into research and development projects and clinical studies, supplier control, management of outsourced manufacturing and general facilities management. Your experience will allow for you to provide support in defining and implementing regulatory strategy for new products and to ensure continuing regulatory compliance.
- Design development and management of a robust and appropriate QMS
- Generation/Review/Update of Standard Operating Procedures (SOP) and ongoing management of the Document Control System
- Management of QA Systems including CAPA, Change Control, Design Control and Deviations
- Drive Risk Management activities
- Manage the employee QMS training programme to ensure effective training is in place
- Manage internal audit programme and identify areas for improvement
- Establish Quality Objectives, monitor performance metrics for reporting to Senior Management Team
- Manage and approve outsourced manufacturing sites and activities
- Manage device manufacture, raw material and device stock control
- Lead compliance of risk management activities for both product launches and product maintenance
- Develop and implement regulatory strategy across projects in both a pre and post market capacity
- Generate records and documentation for inclusion into Technical Files and regulatory submissions
- Lead Internal, third party and regulatory audits
- Monitor and maintain government regulatory registration databases
- Act as liaison with authorities and notified bodies when necessary
- Review promotional information and product literature to ensure regulatory compliance
Skills and Experience:
- Degree or higher qualification in a scientific discipline or similar field
- Experience in an In Vitro Diagnostic and or Medical Device environment in a quality assurance role (e.g. ISO13485, ISO 14971, IVDD 98/79/EC, MDD 93/42/EEC, GCLP, FDA Regulation: CFR part 820)
- Experience with risk management, CAPA management, change control, supplier approval and device validation/verification.
- Understanding of clinical study regulations (GCP) desirable
- Quality Management Training/Lead auditor certification desirable
- Experience with the requirements of UK Human Tissue Act (HTA) desirable
- Experience in medical device manufacturing requirements and supply chain management.
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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