Headcount Solutions is seeking a Supplier Engineer for a client’s Medical Device manufacturing facility. This person will manage suppliers and supplier changes, from an engineering perspective, and to lead opportunities for the reduction of cost, yield or quality improvements with existing or new vendors.
· Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
· In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
· Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same.
· Support the assessment of non-conforming raw materials received from suppliers.
· Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
· Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
· Assess current internal supplier processes to streamline and optimise.
· Liaise with the Purchasing group to identify new suppliers as needed.
· Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
· Collaborate with Purchasing and Legal to ensure the development and implementation of effective supply agreements with suppliers.
· Ensure effective reporting to the Engineering Management team.
· Provide technical support and input when required to the Suppler Audit process.
· Responsible for operating general internal quality systems and documentation.
· Formal Production/Engineering qualification and relevant experience in as least one of the following areas: Manufacturing, Engineering/Device Design & Development/CAPA.
· Strong interpersonal skills and the ability to communicate at all levels of the organisation.
· Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
· Proven Project Management and problem-solving skills.