This is an opportunity to work for a leading medical device business in a Supplier Quality Engineer role. They are seeking a Quality Engineer or Supplier Quality Engineer who has an understanding of the medical device sector.
My client is a leader within medical device technology and together with its customers are driven to make innovative improvements to the healthcare sector. They are seeking an experienced Supplier Quality Engineer who can work in partnership with the Global Supplier Network. With their products and services available in over 100 countries around the world it is an opportunity not to be missed!
The successful candidate will serve as liaison between suppliers and the business to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation. This role will provide coaching and guidance to the SQE team to ensure compliance to technical and regulatory requirements.
Ownership for supplier quality performance and measurement including KPI's and participate in supplier performance reviews
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
- Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
- Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
- Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
- Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers
- Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
- Deliver continuous improvement activities focusing on supplier quality
To be successful in this role you will ideally come from a medical device or automotive experience within an engineering background.
- Bachelor's Degree in Engineering or Science fields
- Minimum of 2 years experience in manufacturing environment or equivalent.
- Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
- Demonstrated working knowledge to positively influence supplier quality performance
- Internal Quality Auditor Qualification either in AS 9100 or ISO13485,CFR820 or comparable industry standards and regulatory requirements
On offer is an opportunity to join a leading business within the medical device sector on a base salary between £40,000 - £50,000 DOE + additional benefits.