Design Quality Engineer

  • CMR Surgical
  • Cambridge Office, 118 Greenhaze Ln, Great Cambourne, Cambourne, Cambridge CB23 5BH, UK
  • Jun 15, 2022
Quality Assurance

Job Description

 

Why 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. Everyone at CMR has the passion and desire to make a real difference to the way minimal access surgery is developed and delivered.

We’re breaking new ground which makes working here exciting, it provides autonomy, opportunity and makes the things you do visible – if you’re great at managing your own time, are creative, patient and resilient, we think you’ll fit right in.

The Role

CMR is now seeking Design Quality Engineers that are competent in Medical Device software, hardware and electrical/electronics.  They will occupy a key position within its Quality Department based in Cambridge, providing guidance and driving compliance on new and existing products and design processes.

Responsibilities

We’re looking for someone who will be passionate about helping us deliver quality in everything we do. In this role, you’ll:

  • Implement the defined design quality processes, procedures, and principles across the business, including involvement in design-related product changes.
  • 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.
  • Support design verification testing, provide guidance in developing and validating test methods, reviewing and approving verification records.
  • Actively engage in the execution of the Quality Plan and Risk Management activities
  • Work with various stakeholders including technology, manufacturing, customers, and regulatory bodies to facilitate corrective action
  • Train and coach others in best practice and the required levels needed to maintain conformance with product and quality requirements
  • Create a culture of continuous improvement
  • Monitoring and reporting quality metrics in the areas of design and design controls
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We’re a high growth company and roles can change and evolve. You’ll need to be willing to turn your hand to anything within the Quality Assurance remit that supports the team with delivering its objectives.

About you

Naturally, given what we do as a company, you’ll have a sound working knowledge of medical device manufacture within an accredited ISO 13485 quality management system or similar regulated industry. We’d also like you to have:

  • A degree in science or engineering-related discipline and/or basic working knowledge of electronics, mechanics and software.
  • Working knowledge and experience in quality concepts like Design for Quality, Quality Function Deployment in new product design and development in a regulated environment, preferably medical device.
  • Development and/or interpretation of technical documentation, e.g., Quality Plans, Manufacturing Protocols, technical drawings, etc.
  • Knowledge of medical device regulations, MDR, MDSAP, ISO 13485 and other global laws and regulations and standards including 21 CFR Part 820, ISO 14971 (including FMEA, DFMEA, PFMEA), IEC 60601-1, IEC 62304, IEC 62366 and related particular standards
  • The ability to demonstrate a hands-on approach to quality design and you won’t be afraid to get involved with any issues as they arise
  • A dynamic and proactive outlook with strong problem-solving skills, a knowledge in quality problem solving tools such as 8D or Lean Six Sigma would be an advantage
  • Ability to process lots of data and information, extract facts, determine a course of action and implement accordingly
  • The willingness to take responsibility and effectively manage your time and multiple tasks to meet deliverables on time
  • Familiarity with document management system, software, internal auditing is an advantage
  • An excellent communicator with strong written and verbal communication skills

Disabled people, women, those from Black, Asian and minority ethnic backgrounds and people over 40 are under-represented in our workforce/team so we particularly encourage applications from people in these groups. We recognise everyone has individual personal circumstances and are open to discussing reduced / flexible / hybrid working hours for this role.

The Package

We offer a competitive salary and a great benefits package including non-contributory pension, private healthcare and a bonus scheme. In addition, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork. CMR is committed to promoting a diverse, open and collaborative work environment – a place where we can be ourselves and succeed on merit. We believe an environment like this is where ideas can truly flourish and balanced with a healthy dose of fun, it ensures that our people stay and develop. We welcome applications to join our team from all qualified candidates, regardless of their characteristics.

Interested? We’d love to hear from you!

#LI-Hybrid 

 

City

Cambridge