About CMR Surgical
At CMR Surgical, we're revolutionising the future of minimal access surgery with Versius, our next-generation surgical robotic system. We're growing fast, and were on a mission to transform how surgery is delivered globallyfor the benefit of patients, clinicians, and healthcare systems.
Our valuesAmbitious, Humble, People-Focused, and Fair & Responsibledefine our approach to innovation, partnership, and growth. If you believe in making a meaningful difference in healthcare and want to be part of a purpose-driven company with bold ambitions, now is the time to join us.
CMR is an exciting and evolving company to be joining right now. Our commitment to our goal of building a world-class medical devices company is underpinned by the ground-breaking innovation of our next generation of surgical robots and a diverse team of talented and supportive individuals.
Were breaking new ground which makes working here exciting, it provides autonomy, opportunity and makes the things you do visible. Come and join us and see what youre capable of.
About the Role
The Quality Engineer role within CMR Surgical (CMR) is a key position contributing to our ongoing commitment to quality management. As a member of the Quality Assurance Department, you will play a crucial role in providing guidance and drive compliance on new and existing products and design processes and facilitating the supplier audit process, fostering continuous improvement, and ensuring the effectiveness of our quality system. Additionally, this role involves providing support for internal auditing and any other quality initiatives.
This position is a hybrid role, with the expectation of at least 3 days a week in our Cambridge office.
Responsibilities
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Work with project teams ensuring all verification, validation and review processes are robust and consistent.
- Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts.
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Support design verification testing providing guidance in developing and validating test methods, reviewing and approving verification records.
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Implement the defined design quality processes, procedures, and principles across the business, including involvement in design-related product changes.
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Developing, planning and conducting supplier audits .
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Coaching and supporting the writing of procedures, instructions, protocols, risk assessments and specification and carry out the relevant document management system updates.
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Maintain and update all supplier information example, but not limited to, Approved Supplier list, Supplier certifications, supplier information in general, audit reports, etc.
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Work closely with Supply Chain and Operations teams to support the supplier management program.
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Drive internal process improvement initiatives.
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Training and guiding employees in identifying and developing problem solving methodologies to resolve quality issues and ensure that relevant quality data/information is properly recorded as per the existing system and procedures.
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Apply best practice to support the achievement of the required levels needed to maintain conformance with the quality management system and regulatory requirements.
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If required support and/or drive actions related to CAPAs and NCRs.
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Position may involve up to 20-30% travel.
Wed expect you to be willing to turn your hand to anything within the Quality Assurance Team remit that helps the team deliver its objectives.
About You
To be successful in this role, youll need to have/be:
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Knowledge of ISO 13485, ISO 14971, ISO 19011, QMSR,MDR, MDSAP
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Knowledge in IEC 60601-1 and collateral standards would also be advantageous.
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An excellent communicator with strong written and verbal communication skills. You are at your best when you partner with the business, effectively interacting & influencing colleagues across all levels & disciplines.
- Minimum of bachelors degree or equivalent education is required or good educational standard with qualifications/college courses relevant to the industry, requirements and job level
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Strong compliance audit background, Internal Auditor / Lead Auditor training is required (preferably to ISO 13485)
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Experience in a regulated industry, such as pharmaceuticals or medical devices.
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Demonstrated success in driving continuous improvement initiatives.
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Familiarity with regulatory requirements (EU MDR and MDSAP).
Why Join Us?
We offer a competitive salary and a great benefits package including a bonus, non-contributory pension, private healthcare, generous annual leave allowance and enhanced global parental leave pay.
Interested? Wed love to hear from you!
This role requires candidates to have eligibility to work within the UK.
Strictly no agencies
