Quality Engineer – Med Devices, Process Validation & CAPA

CMR Surgical; Ely; On-site; GBP 50,000 - 70,000; Full time

Benefits offered by this job

Bonus

Pension

Healthcare

Enhanced parental leave

Job summary

CMR Surgical is seeking a dedicated Quality Engineer in the Operations Quality team at Ely. The role focuses on driving a QE mindset to improve operation processes, with emphasis on process validation and QMS compliance.

The position is on-site at Ely, requiring collaboration across Quality, Operations, Supplier Engineering, and Technology teams. The candidate will own process validation, maintain the SMVP, and lead QE tools such as SPC, MSA, FMEA, and Control Plan, while supporting

Qualifications

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

Responsibilities

• Own Process Validation remit across the Operations team.
• Maintain site master validation plan (SMVP) and Process Validation procedures.
• Create, review, and approve templates, protocols and reports (URS, FAT, SAT, IQ, OQ, PQ).
• Support validation strategy and lifecycle deliverables with SMEs.
• Lead and collaborate on QE core tools (SPC, MSA, FMEA, Control Plan) to meet QMS and regulatory requirements.
• Support NCR, DOA, CAPA, SCAR processes and actions.
• Generate and approve QMS documentation to support Operations Quality and stakeholders.
• Assist audits and ensure compliance with regulations and standards.

Skills

Attention to detail

Integrity

Organisation

Communication

Interpersonal skills

Clerical skills

Computer skills

Education

Degree in science/engineering

Tools

SPC

MSA

FMEA

Control Plan

Job description

CMR Surgical is seeking a dedicated Quality Engineer in the Operations Quality team at Ely. The role focuses on driving a QE mindset to improve operation processes, with emphasis on process validation and QMS compliance.

The position is on-site at Ely, requiring collaboration across Quality, Operations, Supplier Engineering, and Technology teams. The candidate will own process validation, maintain the SMVP, and lead QE tools such as SPC, MSA, FMEA, and Control Plan, while supporting