Senior Quality Engineer
2 weeks ago
Our client is a global medical device and pharmeceutical company who manufacture combination products and also conduct contracted manufacturing. As a Senior Quality Engineer you'll join an expanding team in a broad and diverse role.
The Senior Quality Engineer will support the development of a range of smart medical devices through the full process from initial concept to manufacturing, including the supply chain. You'll work closely with device design engineers and suppliers to ensureall products meet industry standards and regulatory requirements, as well as the needs of customers and partners.
**Role**
The Senior Quality Engineer will be responsible for assessing supplier performance globally. You will engage with CMOs, support audits, conduct investigations and identify process improvements.
Using your knowledge of quality engineering tools such as APQP, SPC and SCAR, you'll be supporting 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 and improving supplier quality,as well as maintaining quality systems and supporting ongoing ISO certification.
**Role**:
- Quality and process validation background, with a good level of exposure to medical devices or combination products
- Conducting audits, both internally and externally, with the ability to evaluate data and identify route causes
- Understanding of all the phases of DMAIC
- 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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