Job Description
A leading medical technology company is seeking a skilled Supplier Quality Engineer to join its global team as part of its expansion. This opportunity allows you to work in an innovative, fast-paced organisation dedicated to improving patient outcomes.
The successful candidate will be responsible for overseeing suppliers globally, ensuring compliance with the company's values and quality standards. This role plays a critical part in developing and maintaining oversight practices for the Supplier Quality function.
Key Responsibilities:
* Conduct audits of key suppliers to ensure adherence to ISO 9001:2016 & cGMP standards.
* Evaluate and approve suppliers in accordance with ISO 13485:2016 & 21CFR Part 820 requirements.
* Administer the Supplier Corrective Action Reports (SCAR) process, ensuring timely investigations and resolution.
* Support suppliers throughout the SCAR process, facilitating root cause analysis when necessary.
* Develop and implement KPIs to effectively manage and monitor supplier quality.
* Assist with new supplier approval processes, including evaluation and re-evaluation.
* Create and update SOPs and WIs related to supplier quality management.
* Investigate suppliers involved in customer complaints or feedback.
* Liaise with suppliers to resolve CA arising from supplier audits.
* Communicate design changes and implemented improvements to suppliers.
* Maintain knowledge of relevant procedures and specifications.
Requirements:
* Bachelor's Degree in Engineering or a related field.
* Experience working in Quality within the Medical Device industry.
* Supplier Audit Experience - ISO 13485.
* Working knowledge of GDP/GMP requirements.
* Excellent organisational skills and attention to detail.
* Ability to travel and work abroad.
* Knowledge of Master Control (Desirable).
Estimated salary range £60,000 - £80,000 per annum depending on experience. Please note that this is an estimate based on industry standards and location.