Quality Engineer - Medical Devices (ISO 13485)

Newton Colmore Consulting; Cambridge; On-site; GBP 40,000 - 65,000; Full time

Benefits offered by this job

Bonus

Pension

Life assurance

Healthcare

Job summary

Newton Colmore Consulting is seeking a Quality Engineer for a Cambridge-based Medical Devices organisation. You will focus on Quality Assurance to ISO 13485 standards and collaborate with mechanical, electrical, software engineers and physicists.

The role involves creating technical files and testing documentation; knowledge of EN 60601 is advantageous. A degree in a relevant field is preferred, and a generous salary along with a bonus, pension, life assurance, healthcare and other benefits are

Qualifications

• Experience with ISO 13485 quality systems for medical devices.
• Knowledge of EN 60601 is advantageous.
• Degree in a field leading to a Medical Devices Quality Engineering career preferred, other routes considered.

Responsibilities

• Create technical files and testing documentation for medical devices.
• Collaborate with engineers across disciplines to ensure quality across development stages.
• Apply Design Assurance practices to product development and validation.

Skills

Quality Assurance

Medical Devices

Cross-functional collaboration

Education

Bachelor's degree in engineering or science

Tools

ISO 13485 knowledge

Design Assurance processes

Job description

Newton Colmore Consulting is seeking a Quality Engineer for a Cambridge-based Medical Devices organisation. You will focus on Quality Assurance to ISO 13485 standards and collaborate with mechanical, electrical, software engineers and physicists.

The role involves creating technical files and testing documentation; knowledge of EN 60601 is advantageous. A degree in a relevant field is preferred, and a generous salary along with a bonus, pension, life assurance, healthcare and other benefits are