QA Tester - Medical Sector

Oho Group
£35 - £50/hour
10 Jun 2017
10 Jul 2017
Contract Type
Full Time
QA / Quality Manager / Quality Assurance / Tester / Medical sector / Contract 

A well-known medical company in the Cambridge area are seeking a QA Engineer to assist on a variety of projects focusing on product development. 

The successful QA Engineer will focus on the development, evaluation and auditing of Design History Files (DHF) internally as well as for our suppliers and clients for a range of products and processes in the medical sector. 

- 2.1 or above in Engineering or other Physical Sciences
- Quality Assurance / Management experience in the medical device and/or pharmaceutical manufacturing/development area
- Experience in FDA 21 CFR Parts 820, 211 and 210 quality system requirements.
- Experience in ISO 13485 quality management system requirements
- Experience in ISO 14971 – Application of Risk Management to Medical Devices
- Risk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEA
- Good knowledge of Design History File Documents; Plans, Design Inputs, Verification, Validation, Design Reviews, Design Outputs

This is an immediate start day rate contract paying a competitive rate.

QA / Quality Manager / Quality Assurance / Tester / Medical sector / Contract