Product Quality Engineer – Medical Devices (Root Cause/CAPA)

OrganOx; Oxford; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Healthcare

Retirement plans

Work-life balance

Job summary

OrganOx is seeking a Product Quality Engineer to join its Oxford-based team. You will monitor and improve performance of the OrganOx Metra, a Class III medical device, working with sustaining engineering and suppliers to implement quality control processes.

You will analyze field data, lead root cause investigations, and help drive CAPAs while collaborating across global teams. The role requires hands-on engineering experience in medical devices and strong analytical skills.

Qualifications

• Demonstrable hands-on engineering experience in the medical device industry or equivalent.
• Knowledge of electro-mechanical troubleshooting techniques.
• Familiarity with ISO14971 and risk management processes is a plus.
• Knowledge of medical device sterilization and microbiology preferred.
• Excellent technical report writing skills.

Responsibilities

• Analyze and trend product performance data to recommend improvements.
• Investigation and disposition of nonconforming material and SCARs.
• Support root cause investigations and CAPA closures.
• Collaborate with cross-functional teams to implement manufacturing/inspection changes.
• Assist in development of investigation criteria and test methods.

Skills

Engineering experience

Root cause analysis

Statistical analysis

Six Sigma

Risk management

Education

Bachelor's degree in Engineering

Tools

MS Office

Minitab

DOE (Design of Experiments)

Job description

OrganOx is seeking a Product Quality Engineer to join its Oxford-based team. You will monitor and improve performance of the OrganOx Metra, a Class III medical device, working with sustaining engineering and suppliers to implement quality control processes.

You will analyze field data, lead root cause investigations, and help drive CAPAs while collaborating across global teams. The role requires hands-on engineering experience in medical devices and strong analytical skills.