Quality Engineer - Medical Devices, On-Site, Benefits

CMR Surgical; Ely; On-site; GBP 60,000 - 85,000; Full time

Benefits offered by this job

Bonus

Pension

Healthcare

Enhanced global parental leave

Job summary

CMR Surgical Ely hosts a pivotal Quality Engineering role within the Operations Quality team. You’ll drive the QE mindset to continually improve processes, manage validation activities, and oversee core tools (SPC, MSA, FMEA, Control Plan) along with CAPA, NCR, DOA, and SCAR processes.

You’ll work on-site at Ely, partnering with Operations, Quality, Supplier Engineering and Technology teams to ensure compliance with ISO 13485 and regulatory standards, supporting audits and improvements across

Qualifications

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

Responsibilities

• Owns Process Validation within Operations Quality, including site master validation plan and related protocols.
• Leads QE core tools like SPC, MSA, FMEA, Control Plan and CAPA activities.
• Supports NCR/DOA/SCAR lifecycle management and data-driven investigations.
• Collaborates with cross-functional teams, audits, and regulatory compliance efforts.

Skills

Attention to detail

Integrity

Organisation

Communication

Interpersonal skills

Clerical skills

Computer skills

Lean Six Sigma

Education

Degree in science or engineering

Tools

PowerBI

Netsuite

SAP

e-QMS (e-DMS)

Qualio

Greenlight Guru

Veeva

ComplianceQuest

IQVIA SmartSolve

Job description

CMR Surgical Ely hosts a pivotal Quality Engineering role within the Operations Quality team. You’ll drive the QE mindset to continually improve processes, manage validation activities, and oversee core tools (SPC, MSA, FMEA, Control Plan) along with CAPA, NCR, DOA, and SCAR processes.

You’ll work on-site at Ely, partnering with Operations, Quality, Supplier Engineering and Technology teams to ensure compliance with ISO 13485 and regulatory standards, supporting audits and improvements across