Quality Engineer II: Device & Risk Management

TekWissen ®; Cambridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading global workforce provider in the UK is seeking a Mid-Senior level professional for the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence. You will lead design control and risk management activities, ensuring compliance with quality standards. The ideal candidate should have a relevant degree with at least 2 years of experience in the pharmaceutical combination product and device industries. This is a contract role offering opportunities in a dynamic team environment.

Qualifications

• Minimum of 2 years of relevant experience in the pharmaceutical combination product/device industries.
• Experience with ISO 13485, ISO 14971, and FDA regulations.
• Familiar with usability engineering and device manufacturing processes.

Responsibilities

• Lead design control and risk management activities for product development.
• Ensure compliance with quality and regulatory standards.
• Support internal and external audits of the Quality Management System.

Skills

Design controls and risk management

Human Factors Engineering

Excellent communication skills

Attention to detail

Ability to work independently

Education

BSc in relevant science or engineering discipline

MSc or PhD in relevant science or engineering discipline

Tools

ISO 13485

ISO 14971

Good Manufacturing Practices (GMP)

Job description

A leading global workforce provider in the UK is seeking a Mid-Senior level professional for the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence. You will lead design control and risk management activities, ensuring compliance with quality standards. The ideal candidate should have a relevant degree with at least 2 years of experience in the pharmaceutical combination product and device industries. This is a contract role offering opportunities in a dynamic team environment.