Role:- Quality & Regulatory Officer (Medical Device)
Salary:- £30-35,000 P/A
Russell- Taylor Group have a fantastic opportunity for an individual who has a minimum of 3 years quality experience and who has worked in a medical device environment to join our clients Global Life Sciences company in Bury. If you are a trained auditor and have worked to ISO 13485 standards please apply within.
- Implement and maintain the QMS (planning, certification, accreditations to ISO standards). Issue, review & approval of the QMS documentation (SOPS, validation protocols etc)
- Engage with stakeholders as the representative for the site in Bury
- Perform and maintain CAPAS and internal audits, aswell as ensuring that any external audits are performed and then reported as scheduled.
- Understand, lead and maintain the ISO 9001 AND ISO 13485 accreditation as well as the laboratory to ISO 17025
- Maintain IVD files and MHRA registration for compliance
- Manage product registration with CE marked products
- Ensure effective communication between all of the company's sites to ensure that regulatory requirements are met
- Understand, control and maintain the Quality Management Systems software policy (QPulse). Provide training for the QPulse system.
- Implement the risk management system
- Warrant compliance to BSE/TSE legislation for raw materials
- At least 3 years' experience working within quality management systems (QMS)
- Experience working in medical device/ISO 13485
- Trained auditor
- Understanding on certification/accreditation schemes
- Track record of representing the quality side of the business to external stakeholders