Quality Engineer

4 weeks ago

Chippenham, United Kingdom Real Staffing Full time

Our client is a global medical device manufacturer with their own products along with contracted manufacturing capability. They are looking to expand the Quality team by adding a Senior Quality Engineer.

**Role**:
The Senior Quality Engineer will support the development of a range of medical devices. Working as part of the team and closely with device design engineers and suppliers to ensure all products meet industry standards and regulatory requirements.

The Senior Quality Engineer will be responsible for assessing supplier performance, engage with CMOs, support audits, conduct investigations and identify process improvements.

Using your knowledge of quality engineering tools and SCAR the Senior Quality Engineer will support supply chain and device industrialisation teams to ensure devices are manufactured to relevant industry standards and regulatory requirements.

The Senior Quality Engineer will work closely with the production line to identify production trends, carry out audits and recommend quality standard updates.

This will include overseeing incoming materials, reducing scrap, validation of products and equipment and improving supplier quality.

**Skills**:

- Quality engineering and validation, with a good level of exposure to medical devices or combination products
- Audits, both internally and externally, with the ability to evaluate data and identify route causes
- Understanding of all aspects of the phases of DMAIC
- Statistical approach (e.g. SPC etc.)
- Any exposure to medical devices or working with CMOs would be beneficial, but isn't essential.
- Working knowledge of quality assurance standards - e.g. ISO 13485 etc.

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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