Quality & Regulatory Officer

Role:- Quality & Regulatory Officer (Medical Device)

Salary:- £30-35,000 P/A

Location:- Bury

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.

Responsibilities

• 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

Role

• 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

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k