Supplier Quality Engineering Business Partner – Cambridge, MA
In this role, you have the opportunity to
Lead in a Principal level Individual contributor role and own the implementation of Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain.
You are responsible for
You will partner with R&D, Operations and Procurement personnel to actively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers.
Developing and supporting regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
You will lead additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records.
Ensuring raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed requirements.
Performing 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
You will 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 will guide, manage and implement transparency within the organization and work closely with MT leadership/stake holders to drive key metrics to pro-actively improve supplier quality performance and reduce business revenue impact due to FCO’s, supplier QN notices, unintended disruptions, and resolve supplier issues to business and regulatory compliance satisfaction.
You are a part of
Philips playing a central role in improving people’s lives. Population Insights & Care and VitalHealth deliver solutions that support the transformation of healthcare organizations as they work to improve quality of care and patient outcomes while managing costs and resourcesBoth businesses are part of the Population Health Management group, which is a domain area that Philips is investing in as part of its strategy to transform healthcare. These businesses are leading solutions providers to a wide range of customers such as large, nationwide health systems and Integrated Delivery Networks (IDNs), Accountable Care Organizations (ACOs), clinically integrated physician networks, health plans, and employers. Note that Philips will be relocating to a new office site at Cambridge Crossing, a large development underway on the Cambridge-Somerville-Boston line. This is a very exciting time to be joining Philips, as this new location will be our largest North American R&D innovation center. The new office is set to open in early 2020.
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) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course.
7+ years of Supplier Quality Engineering experience
7+ years of related experience in a medical device or regulated industry.
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.
Expert level knowledge of methodologies, tools and techniques in Purchasing, Operations and SQE including due diligence processes.
4+ years of management experience.
Preferred to have broader experience including procurement, manufacturing engineering and project engineering.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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.