Quality Assurance Officer - The One Group : Job Details

Cambridge is well-known for its cluster of Medical Device organisations but this one really is genuinely one of the special ones.

With their ethos at the heart of what they do, they are passionately working towards saving thousands of lives through enabling the early detection of cancer and other diseases.

Within a fun team of around 200 people based on Cambridge Science Park, the Quality team is growing and they are looking for an additional Quality Assurance Officer to be key to the ongoing success of the company as they work towards 13485 status in 2025, as well as keeping them compliant to 9001 and 21CFR Part 820.

You should be comfortable working in an R&D organisation, who are still very much on a 'journey'!

Supporting the QA Manager (who is lovely - The ONE Group recruited her!), your role will be to:

• Maintain all aspects of the QMS, including; Change comtrols, Non-conforms, CAPAs & Complaints
• Support continuous improvement within the QMS and maintain compliance by conducting internal audits
• Provide support for notified bodies and client audits
• Report on QMS metrics
• Induct new starters on Quality aspects

What you need to apply:

• Life Sciences degree
• Trained lead auditor (internal)
• Experience carrying out all tasks outlined above
• Experience writing quality procedures
• Strong presentation skills
• Working knowledge within a Pharma/Med Device QA team, including GxP and Quality regs and standards
• Must have 9001, 13485 and GCP
• 21CFR Part 820, 17025, Clinical Trials, 13485 Lead external auditor would be highly advantageous
• Experienced with Electronic Document Management Systems

What's in it for you?

• Employee share options scheme
• Private medical insurance
• The Quality team work collaboratively and are on-site 4 days per week and WFH 1 day per week (this can be flexible)
• Friendly and relaxed working atmosphere with a genuine team spirit
• On site 'wellness room'
• Standing desks available
• Free lunch every Friday!
• Gym
• Food trucks
• Fun social activities, including gliding!