Quality Design Engineer

4 days ago

North Yorkshire, United Kingdom Real Staffing Full time

**Design Quality Engineer**

Our client is a global medical device company developing, manufacturing and distributing a variety of medical devices is looking for a Design Quality Engineer to join their team. This company operates worldwide and has grown to over 500 people.

The Design Quality Engineer will be responsible for design quality input and support various projects focusing on design control, risk management, usability and general Regulatory Compliance support.

**Responsibilities**:
**Design Controls**
- Establish Design Control requirements ensuring compliance to all applicable standards
- Creating retrospective Design History Files for legacy and acquired products
- Deliver design transfer activities as part of New Product Development, ensuring transferred systems are understood and coordinated into the Quality System
- The Design Quality Engineer will develop effective Process Verification Strategies applicable to the department
- Provide reliability objectives & assessment plans for Product Development and sustaining team
- Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, re certification, and brand extensions

**Risk Management**
- Risk Management oversight, input, and review during DHF development and product life cycle phases in accordance with ISO14971
- The Design Quality Engineer will create retrospective Risk Management Files for legacy and acquired products
- Driving the creation of or changes to appropriate Risk Management maintaining this plan to all phases of the product's life cycle
- Deliver design transfer activities as part of New Product Development, ensuring transferred systems are understood and coordinated into the Quality System
- Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques to minimise potential risk during development/implementation activity.

**Usability**
- Responsible for establishing and maintaining a Usability Framework for the Organisation
- Create and maintain Usability files where needed, ensuring linkages with Risk Management, Design and Clinical activities
- Ensure compliance with all detailed Quality system, as per FDA QSR's and ISO 13485/9001 requirements etc. during day-to-day activities
- Supports regulatory with validation related technical file maintenance and updates, essential to fulfil our CE Certification, and to meet changing regulatory requirements

**Requirements**:

- Life Sciences, Engineering degree or experience in a quality, regulatory or technical role
- Knowledge of FDA, ISO, and other specific Quality System requirements specific to Medical Device

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales

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