Philips Supplier Quality Engineer in Shanghai, China
Produces and completes Supplier Quality Engineering related activities and documentation under direct supervision.
Assists in the Qualification of Parts, identification of supplier processes for CtQ's, supplier process control plans to ensure part quality; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
Assists in qualifying and sustaining sub-processes of suppliers, including supplier audits.
Assists in ensuring that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements.
Supports SCAR management, effective and timely closure and Review/risk assessment of QN's and their escalation to SCARs where needed.
Supports efforts to establish common approaches and working methods to drive ‘’One Philips ’’ towards Supply Base in the assigned BG or Market.
Assists efforts in assuring that suppliers’ process capabilities are assessed to meet part quality requirements, specifications are complete, transferable to suppliers, and well documented
Assists efforts in control plan and part quality plan deployment by supplier as specified by Philips to ensure parts from supplier consistently meet specifications
Assists in supplier qualification process and ensuring part quality requirements are met
Assists and supports establishment of Receiving Acceptance Plan for purchased parts.
Assists and supports establishment of measuring and monitoring supplier quality performance per established measures and metrics (KPIs) for part quality
Guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Key areas include:
5+ years hands on experience in APQP process and related quality support tools (process flow / D & P –FMEA / control plan methodology / SPC / MSA / PPAP knowledge) and effectively implement all these tools as part of New Product Introduction for multi project environments.
Must be able to perform supplier QMS and process / product audits at supplier locations chosen for NPI projects
Being a certified auditor, holding CQA / CQE certs and/or Medical ISO 13485 / CFR 820 QMS are all pluses.
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
For over 10 years, Philips Ultrasound (Shanghai) Co. Ltd., has been a leading company in design, develop and manufacture medical ultrasound transducer for variety of applications. The company has become member of Philips Healthcare since 2010 and continues actively to provide high quality, high performance products to medical ultrasound customers.
This position will be located in Pudong, Shanghai, China.
In this role, you have the opportunity to
Support on-site/off-site supplier quality development, Manage quality conformity of supplies, Execute the contractual definition and agreement on product and process specifications with the supplier, Support incident related liability recovery (CoNQ)
Your Key Responsibilities:
Independently Produces and completes Supplier Quality Engineering related activities and documentation.
Ensures that the components/products at the supplier (including spare parts and services) are released accrding agreed specification and qouality requirements (APQP / PPAP), and SQ auditing results.
Ensures that suppliers’ process capabilities are assessed to meet part quality requirements, specifications are complete, transferable to suppliers, and well documented.
Leads support efforts in the establishment of measuring and monitoring transducer supplier quality performance per established measures and metrics (KPIs) for part quality Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a project team.
You are a part of
The global SQE Team, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. SQE Team is one of the five Centers of Excellence (COEs) in Philips Global Quality Organization. These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit.
To succeed in this role, you should have the following skills and experience
Education: Bachelor’s degree in an engineering or science discipline, Current auditor certification with a recognized Accreditation body such as ISO-9001:2015 / ISO-13485, etc. Experience: More than 8 years of total industry experience (automotive industry is most desirable, then aerospace, then medical), with 4+ years of related experience in a regulated industry in supplier quality engineering function is a must.
Competencies and skills:
Very strong auditing skills sets from QMS / Process / Risk audit standpoint is a Must.
Very strong knowledge in application / deployment of APQP / PPAP process at supplier level for new product introduction at supplier level.-Must.
Expertise/experience in problem solving(root cause analysis, corrective and preventive action methods) with quality tools is a Must, such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.
Working knowledge of appropriate global medical device regulations, requirements and standards is a plus, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.-Nice to have
Strong knowledge of mfg. Operations and supplier quality development process and control methods; CtQ definition, DfSS, SPC
Good leadership and cross-functions coordination skill.
Fluent in English and Chinese Langauge is a MUST.
In return, we offer you
A promising professional career development platform. Work in the medical industry brings much fulfillment, as well as unique challenges, you will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .