Proclinical are seeking a Quality Manager (QM) to join our amazing team in Cambridge. The QM will play a key role in managing the Quality Management System and oversee the various associated duties within an ISO 13485 environment. The QM will take responsibility for leading, co-ordinating and monitoring processes such as change control, corrective actions, risk management and ensuring that all requirements are met and records are completed. The QM will be required to provide technical and quality support for projects, ensuring relevant data is completed by the development teams
- Ensuring compliance with the requirements of the Quality System for implementation of ISO 13485.
- Planning, initiating and managing quality improvement projects.
- Acting as a point of contact with accreditation authorities, including arranging and planning for assessments.
- Perform internal audits to ensure compliance to external regulatory requirements.
- Assisting in audits relating to Quality Management Systems and the In-Vitro Diagnostics Directive. Ensure corrective actions are implemented for issues arising from those audits.
- Lead in the role of Risk Management; with knowledge of ISO 14971.
- Assist with drafting and compiling design history files in compliance with IVD regulations and standards for regulatory submissions.
- Ensuring changes to any relevant standards are adopted in a timely manner.
- Gather non-conformance data, investigate and implement effective Corrective And Preventative Actions (CAPA).
- Support with compilation and updates on technical file and other relevant documents.
Skills and Requirements
- Undergraduate degree in a science, medical or technical field
- Over 2 years' experience of working in an ISO 13485 environment and IVDR submissions for software based IVD's
- Lead auditor qualification (desirable)
- Implementation and/or maintenance of ISO 13485 certificationManaging an e-Quality Management System (e-QMS)
- Experience with writing concise and accurate reports
- Working under pressure in a fast-paced environment
- Creation of complex spreadsheets
- Working with multiple parties to edit and refine complex word documents
- Participating in internal and external audits
- Understanding of software-based medical devices field (desirable)
- Working knowledge of other applicable standards including IEC 62304, ISO 14971, and ISO 15189
- Outstanding attention to details
- Self-motivated and able to work autonomously and problem solve in an ever-changing work environment
- A knowledgeable, high-achieving, experienced and fun team
- The chance to be part of a growing start-up and the next leader in building integrated diagnostics by combining molecular biomarkers with digital solutions
- Perks at work scheme
- Free tea and coffee in offices
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.