Quality Engineer - Ops

CMR Surgical; Ely (MN); On-site; USD 87,014 - 120,482; Full time

Benefits offered by this job

Bonus

Pension

Healthcare

Parental leave pay

Job summary

CMR Surgical Ely site is seeking a Quality Engineer to drive the QE mindset across operations. You will own process validation, support GMP/ISO 13485 compliance, and lead key quality tools to improve manufacturing processes.

This full-time, on-site role requires cross-functional collaboration with Operations, Quality, Supplier Engineering and Technology, with occasional travel to support audits and CAPA activities; experience with MDSAP, QMS/ERP tools, and Lean Six Sigma is highly valued.

Qualifications

• Degree in science, engineering or equivalent.
• Typically 5 years Quality Engineering experience in medical devices or healthcare.
• Experience with ISO 13485 and regulatory requirements.

Responsibilities

• Own Process Validation end-to-end across the Operations team.
• Lead Quality Engineering core tools implementation and improvements.
• Address NCR/DOA/CAPA/SCAR requirements and support audits.
• Collaborate with Operations, Quality, Supplier Engineering and Technology.

Skills

SPC

MSA

FMEA

Control Plan

NCR

CAPA

Minitab

JMP

PowerBI

Netsuite

SAP

e-QMS

Lean Six Sigma

Internal Auditor

Education

Degree in science/engineering

Tools

PowerBI

Netsuite

SAP

e-QMS

Job description

AtCMR Surgical, we’re revolutionising the future of minimal access surgery withVersius, 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 & 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.

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.

About the Role

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.

Responsibilities

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 timely closure and effectiveness of actions for Operation and Operation-Quality related CAPAs.
• Review and approval (closure) of NCR / SCAR / DOA.

Generates, reviews / approves MCR, CN, Concession (Deviation), QMS documentation (QP, WI, QD) to support Operation, Operation-Quality, and other relevant stakeholders.

Supports internal and external / 3rd party audits as well as ensuring compliance with relevant regulations and industry standards.

Covers Quality Engineer and Operation Quality Manager function when needed (e.g. holidays) – CRB, NCR / DOA / CS / QMS documentation approvals; management of the team, etc.

• Process Validation – end-to-end (URS-to-PQ) including writing, review, and approval of proto-cols and reports and lifecycle deliverables e.g. URS, master validation plan, site master validation plan, validation deviation.
• Quality Engineering core tools (SPC, MSA, pFMEA, Control Plan) – implementation (roll out) e.g. from concept to execution including training and mentoring of SMEs; writing MSA (GR&R) pro‑tocols and reports,
• Regulated environment – proven experience and understanding of MDSAP, ISO 13485, MDR / MDD, UKCA, GMP (Pharma).
• Statistical analysis including use of statistical tools / software (Minitab, JMP).
• High proficiency in MS Office tools.
• NCR / CAPA / DOA / SCAR – leading / implementing / facilitating timely progress including root cause analysis (RCA) tools e.g. WHY-WHY analysis, Fishbone, Fault Tree Diagram as well as problem solving tools e.g. 8D.
• QMS and ERP software – experience with PowerBI; Netsuite / SAP; and e‑QMS (e‑DMS) e.g. Qualio, Greenlight Guru, Veeva, ComplianceQuest, IQVIA SmartSolve.
• Lean/Six Sigma (Green or Black Belt) in process improvement (manufacturing / operation).
• Internal/Lead Auditor trained to ISO 13485.
• Quality Plan – use & implementation in conjunction with QMS processes e.g. change control.

About you

• Continually challenge status‑quo and drive continuous improvement mindset to meet business current and future needs e.g. efficiency, having practical (pragmatic, sustainable) processes and systems without compromising Quality (patient safety).
• Fosters a culture of continuous improvement and quality‑focused (engineering) mindset.
• Attention to detail, integrity, organisation, communication, and interpersonal, clerical and computer skills.
• Effective communicator who can confidently engage with various stakeholders.
• Creative / methodological / pragmatic approach to problem solving (Investigation, RCA).
• Resilient and comfortable working in a fast‑paced working environment, or by a wide range of tasks.
• Professional and good team player.

Qualifications:

• Minimum of Degree or equivalent in a science, engineering or similar subject.
• Typically, 5 years’ Quality Engineering experience in medical devices, pharmaceutical, healthcare.

Additional Information:

• Relevant transferable experience and the potential to develop into the full scope of the role will be considered, even if candidates do not meet every listed requirement.
• We’d expect you to be willing to turn your hand to anything within the Operations Quality remit that helps the team deliver its objectives.

At CMR we’re building a diverse, inclusive, and authentic workplace; what matters most to us is that you identify with our values and are passionate about making a difference.

Why Join Us?

We offer a competitive salary and a great benefits package including a bonus, pension, healthcare and enhanced global parental leave pay.

Interested? We’d love to hear from you!

This role requires candidates to have eligibility to work within the UK. Strictly no agencies.