Supplier Quality Engineer

Job Description Summary

Ensures the annual definition of the quality improvement plan (QIP) based on business needs and timely implementation. Supports on-site/off-site supplier quality development including coordination /management of required internal/external resources. Manages the early involvement of suppliers in new product development and product/component improvement. Leads quality system audits. Coaches and manages the SQE team ensuring the competences and capabilities are in line with the business needs. Deploys and follows-up on the Supplier Quality Related KPI’s towards the supplier. Ensures the assigned supply base meets the Philips sustainability requirements. Ensures the timely and correct GSRS data-input. Participates in the Supplier

Selection process for the quality aspects. Sets supplier quality aspects for new / improved products ensuring a.o. manufacturability aspects at suppliers (improve supplied quality).

Job Description

You will be part of the Next Generation Scanner project team, responsible for supplier part- and product Quality. You work closely with the Procurement and Development Quality Functions. You report to the Head of Quality.

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.