In this role you will 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.
You are responsible for
Independently producing and completing Supplier Quality Engineering related activities and documentation.
Completing Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
Qualifying and sustaining sub-processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
Ensuring that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results.
Independently working to deploy common approaches and working methods to drive ‘’One Philips’’ towards Supply Base in the assigned BG or Market.
Part Qualification for Product Lifecycle Maintenance
Partner with Design Engineer and Advance Quality Engineering to determine Part Qualification requirements
Partner with Advance Quality Engineer to plan special process validation activity
Complete Part Qualification / Special Process validation activities
Maintain Receiving and Inspection Plans
Manage Supplier Change Request
Supplier Oversight & Monitoring
Perform monthly supplier monitoring based on non-conformance data received from the factory and field
Facilitate quality review meetings
Initiate cross-functional Supplier Quality Improvement Plans/Projects or SCARs based on data analysis/trending and outcome of quality review meetings
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in an engineering or science discipline, or equivalent experience.
Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) an
5+ years of total industry experience
Experience in working with part qualifications
Working knowledge of appropriate global medical device regulations, requirements and standards 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.
Familiar with Quality tools such as: Six-Sigma, 8-D, CAPA, FMEA, 5WHY, APQP, etc.
Experience in root cause analysis, corrective and preventive action methods .
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/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.