- Innovative Medical Technology company, conducting cutting edge research
- Autonomous role: Take ownership of the progression of QMS systems
- Competitive Salary Package, with further benefits
- Cambridge based role
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 Management Specialist is required to join their team in Cambridge.
As an experiences QMS, you will take ownership for the development and maintenance of a comprehensive quality management system, including CAPA, change controls, design control and risk management activities. You will be responsible for ensuring all QA requirements comply with relevant standards. Additionally, you will act as Quality Assurance support for Research and Development, Manufacturing and Validation activities.
- Relevant QA input into research and development projects and clinical studies.
- Manage and collate device design history files for marketing and sales activities
- Supplier control - manage and approve outsourced manufacturing sites, maintaining strong external relationships
- 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 ensuring all documents are held securely and readily available.
- 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 the internal audit programme to ensure compliance with the QMS and identify areas for improvement.
- Establish Quality Objectives, monitor performance metrics for reporting to Senior Management Team.
Skills and Experience:
- Degree or higher qualification in a scientific discipline or similar field
- QA experience within a Medical Device or In Vitro Diagnostic environment
- Strong understanding of ISO13485, 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)
- Exceptional communication skills, with the ability to collaborate both internally and externally
- 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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