Why join us?
CMR is one of the UK’s most exciting companies to be joining right now. The scale of our ambition to build a world-class medical devices company in Cambridge is matched only by the breath-taking innovation that underpins our next generation of surgical robot. We’re an award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world.
Our values are ambitious, humble, people focused, fair and responsible. If you share these values, our passion for improving lives, and have the skills to make a real difference to the way minimal access surgery is developed and delivered, then it’s a great time to join us.
Every day will be different, but some of your main responsibilities will be:
- Maintaining good relationships with Supply Chain, Engineering, Manufacturing, and R&D departments
- Assuring consistent supplier performance & assisting in the development & implementation of supplier management programmes
- Creating or assisting in supplier risk assessments and identifying areas which are critical to quality
- Assess suppliers either remotely or on site. Being a certified Lead Auditor (ISO-13485:2016 preferably) is an advantage
- Monitoring supplier performance and addressing issues when they arise.
- Either lead or monitor investigations where necessary. Demonstrable experience in root cause analysis is an advantage.
- Facilitating corrective action and preventive actions aimed at addressing supplier quality issues, this includes ensuring appropriate investigations associated with product, supplier performance, and complaints
- Facilitating RoHS and REACH compliance
- Generating, reviewing and approving of supplier quality-related support documentation
- Reporting supplier performance and quality to management
- Support with maintaining Approved Supplier List
- Experience in facilitating the negotiation process and the completion of quality agreement with suppliers is an advantage
- Reviewing supplier component documentation including 8Ds, dimensional and material reports for sign off acceptance.
- Working with Supply Chain and suppliers to facilitate New Product Introduction to include witnessing production component readiness i.e. Installation Qualification, Operational Qualification and Performance Qualification runs’
We’re a high growth company and as such roles change and evolve. We’d expect you to be willing to turn your hand to anything within the Quality remit that helps the team deliver its objectives.
A natural communicator hopefully goes without saying, but in addition we’d like you to have:
- A thorough understanding of Quality Management Systems (ideally the requirements of ISO13485 and FDA 21 CFR part 820)
- Ability to work with suppliers, driving part/s quality improvement projects.
- Experience of PPAP,ISIR, FAIR, Validation process etc… would be an advantage.
- Knowledge of RoHS and REACH requirements
- Working within the medical device industry ideally with mechanical, electronic or electrochemical technologies
- Practical knowledge & experience in a range of quality techniques, methods and tools, particularly root cause analysis
- A genuine desire to help and support team members so we collectively deliver quality objectives.
We offer a competitive salary and a great benefits package (including non-contributory pension scheme, cycle-to-work scheme, life assurance, and our infamous monthly BBQs). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.
Interested? We’d love to hear from you!