The role is based at Mologic Ltd (Thurleigh), an innovative healthcare diagnostics company.
You will work with and report directly to the Quality & Regulatory Affairs Manager.
You will assist in the maintenance and improvement of Mologic’s ISO 13485 quality management system:
- develop and maintain the QMS and associated documentation (SOPs, batch records, training records etc.)
- assist in internal and external audits and Corrective & Preventive Actions (CAPAs)
- ensure quality records are established and maintained
- proactively seek to improve Quality and Regulatory Affairs awareness and compliance
- prepare for upcoming external audits
- Qualifications and Skills.
Minimum 3 years’ experience in ISO 13485 Quality Management Systems in an in vitrodiagnostic medical device company.
Experience in MDSAP (specifically Canada, US, AUS) would be advantageous.
Flexible team worker. Good attention to detail.
Job Type: Full-time
If this opportunity is of interest to you, then we want to hear from you.
Please send your CV and a cover letter to:
More details on our Web site: