Quality Engineer CV-Library Quality Engineer

Scienceabode; Cambridge; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Human Factors Quality Engineer for a 12-month contract role based in Cambridge. This hybrid position entails leading design control and risk management activities for combination product development. Applicants should hold a relevant scientific degree and possess knowledge of ISO standards and Good Manufacturing Practices. The salary ranges from £25.98 to £29.12 per hour depending on the employment type, with 50% onsite requirements.

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.

Responsibilities

• Lead design control and risk management activities for combination product development programs.
• Support effective risk management activities at external design companies and manufacturing facilities.
• Ensure combination product development activities are compliant with all required standards.

Skills

ISO 13485

Risk management

Human Factors Engineering

Good Manufacturing Practices

Education

Relevant scientific degree

Job description

CK Group are recruiting for a Human Factors Quality Engineer to join a company in the pharmaceutical industry on a contract basis for 12 months. This is a hybrid role with 50% onsite in Cambridge.

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

Human Factors Quality Engineer Role

• Lead design control and risk management activities for combination product development programs
• Support effective risk management activities at external design companies and manufacturing facilities
• Ensure combination product development activities are compliant with all required standards
• Support the generation of all regulatory submission data

Your Background

• 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.

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.

£25.98 – £29.12/hour