Supplier Quality Engineer

Supplier Quality Engineer

Responsibilities

● You partner with R&D, Operations and Procurement Engineering to actively engineer quality and ensure compliance for components, Software, finished products etc., from suppliers.

●You detect and support resolution of quality- and compliance gaps at suppliers.

● You lead additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records.

● You ensure raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed requirements.

● You drive quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements.

● Driving shared accountability across stake holders to design, manufacture and distribute products right the first time from our supplier base.

● You drive product implementation/Changes/Transfers accordingly the Philips requirements (NPIs, PDLM, APQP)

● You are responsible to managing SCARs, supplier QN’s, unintended disruptions, and resolve supplier issues to business and regulatory compliance satisfaction.

● Performing of Supplier Audits and leading Supplier Quality Improvement programs as needed to support the next Generation Scanner project.

To succeed in this role, you should have the following skills and experience

● Experience with working in cross functional Prouct Development projects.

● Experience with managing Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP) for systems development.

● Bachelor’s degree in an engineering or science discipline, or equivalent experience.

● 6+ years of total industry experience

● 6+ years of related experience in a medical device or regulated industry (E.g.: Automotive)

● Working knowledge of appropriate global medical device regulations, requirements and standards such as FDA 21 CFR Purchasing Controls 820, ISO13485, ISO14971, IEC 62304, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282) and ISO 9001.

● Expert level knowledge of methodologies, tools and techniques in Purchasing, Operations and SQE including due diligence processes.

● 4+ years of Project management experience

● Preferred to have broader experience including procurement, manufacturing engineering and project engineering.

● Excellent commination skills and experience in performing of Supplier Audits