Quality Engineer - Ops

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 we’re on a mission to transform how surgery is delivered globally for the benefit of patients, clinicians, and healthcare systems.

Our values—
Ambitious, Humble, People-Focused, and Fair & Responsible
define 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.

We’re 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 you’re capable of.

You’ll be part of a close-knit and dynamic Operations Quality team.

Overall responsible for driving Quality Engineering (QE) mindset to continually improve Operation processes. These are (primarily) but is not limited to Process Validation e.g. creating/approving proto-cols & reports, maintenance of SMVP; and QE core tools e.g. Statistical Process Control (SPC), Measurement System Analysis (MSA), pFMEA, Control Plan as well as (secondary) NCRs, DOA, CAPA e.g. managing, analys-ing data, driving improvements and effectiveness of Corrective & Preventative Actions, reporting metrics / KPIs / dashboard (landscape, visibility).

This is a full-time, permanent on-site role based at CMR Surgical Ely site.

The role is primarily site-based due to the need to support Operations Quality, manufacturing process-es, investigations, audits and cross-functional activities, in line with business needs and company policy.

The role does not currently have direct line management responsibility but will require strong cross-functional influence and collaboration across Operations, Quality, Supplier Engineering, Technology and other relevant teams. Occasional travel may be required to support suppliers, audits, training or other business needs.

This role is based on-site at our Ely premises.

Process Validation – owns this remit across the Operation team.

• Maintenance of site master validation plan (SMVP) and Process Validation procedure including update, streamlining, compliance to CMR QMS and regulatory requirements e.g. ISO 13485 and medical device / pharmaceutical best practices.
• Creates, reviews, approves templates, protocols and reports e.g. master validation plan, URS, FAT, SAT, IQ, OQ, PQ in collaboration with SMEs.
• Support and collaborates with Operation team e.g. validation strategy and lifecycle deliv-erables, documentations, etc.

QE core tools (SPC, MSA, FMEA, Control Plan) – leads, implements, streamlines, improves, and collaborates with SMEs.

• To address Operation current and future needs including continuous improvements as well QMS requirements e.g. NCR, DOA, CAPA, SCAR.
• Creates, updates, reviews, approves, streamlines templates and procedures to meet CMR QMS and regulatory requirements e.g. ISO 13485 and medical device / pharma-ceutical best practices.

NCR / DOA / CAPA – supports (primarily) or/and leads, manages the day-to-day cadence e.g. Triage; MRB NCR Review Board (NCRB); NCR Clinic; timely progression and closure against relevant metrics.

• Collaborates with key stakeholders for timely progress of NCR / DOA / SCAR (when needed) e.g. writing up (updating) Containment Action, Corrective Action, Preventative Ac-tion, Investigation (RCA) as well as ensuring effectiveness of actions.
• Analyses data, publishes reports (metrics) KPIs, and proactively drives actions for NCR / DOA / CAPA / SCAR e.g. overall status / landscape; progress and timely closure;
  Pareto analysis of key issues; reduction / preventing recurring and systemic issues; identify areas for improvement; NCR escalation to CAPA.
• Manages and collaborates with key stakeholders the visibility, drive…