Design Assurance

A global medical device company is seeking two experienced Design Assurance Contractors to support growing programme activity across R&D, Quality and Regulatory.

You'll support medical device programmes across new product development, design changes and design transfer. The role will focus on Design Controls, MDR Technical File remediation, risk management and the creation, review and approval of compliant design documentation.

Essential Skills

• Design Assurance and Design Controls experience
• MDR Technical File remediation experience
• ISO 14971 Risk Management
• DHF, Technical File and risk documentation
• Design Verification and Validation support

Desirable Skills

• Experience with ISO 13485 and Good Documentation Practice
• CAPA, non-conformance or audit support experience

This is a strong fit for Design Assurance contractors with a proven track record of remediation and compliance-led medical device projects who can work effectively across R&D, Quality and Regulatory teams.

Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.

To find out more about Real, please visit (url removed)

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC(phone number removed) England and Wales