Quality Engineer in Cambridge

Energy Jobline CVL; Cambridge; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A leading engineering job board in Cambridge is seeking a Human Factors Quality Engineer. The role involves leading design control and risk management activities for combination product development. Applicants must hold a relevant scientific degree or equivalent experience, and have knowledge of ISO standards and Good Manufacturing Practices. The position offers flexible working, with 50% home working.

Qualifications

• Hold a relevant scientific degree or have equivalent working experience.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, and EU Medical Devices Regulation.
• Experience in design controls and risk management for combination products.

Responsibilities

• Lead design control and risk management activities for product development.
• Support risk management activities at external design companies.
• Ensure compliance with quality and regulatory standards.

Skills

Knowledge of ISO 13485

Knowledge of ISO 14971

Experience in design controls

Familiarity with Human Factors Engineering

Understanding of Good Manufacturing Practices

Education

Relevant scientific degree or equivalent experience

Job description

Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide.

We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.

Human Factors Quality Engineer (Contract, 12 months)

Salary: Up to £25.98 per hour PAYE or up to £29.12 per hour via umbrella company.

Role

• Lead design control and risk management activities for combination product development programs
• Support and facilitation of effective risk management activities at external design companies and manufacturing facilities
• Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external
• Support the assessment of external design companies and suppliers
• Support the of all regulatory submission data and content for assigned device projects

Qualifications

• Hold a relevant scientific degree or have equivalent working experience
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
• Experience in design controls and risk management for combination products
• Familiar with Human Factors Engineering - Usability Engineering
• Familiar with device assembling manufacturing processes
• Understand Good Manufacturing Practices (GMP)

Company

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location

This role is based at our clients site in Cambridge 50% and 50% home working.

Apply

For more information, or to apply for this Human Factors Quality Engineer please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only).

It is essential that applicants hold entitlement to work in the UK.

Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

INDKA

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.