Philips Supplier Quality Engineer in Reedsville, Pennsylvania

KPI's

  • Purchased part quality (existing – new NPI projects, Legacy, Service, BOM Cost Savings, SCA-SCN product –process changes)

  • Quality improvement trending ( % QN reductions, DPPM)

  • Supplier/part qualification ( % of planning & completion KPI realized, open audit findings, effective closure)

  • SCAR completion ( % closed within agreed timeframe, effective closure)

  • Quality Reviews ( % of planning % completion realized, other)

Existing – New NPI Project book completion as assigned (consumer personal health products/services)

Job Overview

  • Independently Produces and completes Supplier Quality Engineering related activities and documentation.

  • Completes Qualification of materials and components (including spare parts), supports 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.

  • Qualifies and sustains sub-processes of suppliers, including performing process validations for critical supplier processes impacting part quality.

  • Ensures 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.

  • Executes SCAR management, effective and timely closure and Review/risk assessment of QN's and their escalation to SCARs where needed.

  • Independently works to deploy common approaches and working methods to drive ‘’One Philips’’ towards Supply Base in the assigned BG or Market.

  • Ensures that suppliers’ process capabilities are assessed to meet part quality requirements, specifications are complete, transferable to suppliers, and well documented

  • Ensures efforts in control plan and part quality plan deployment by supplier as specified by Philips to ensure parts from supplier consistently meet specifications

  • Ensures in supplier qualification process and ensuring part quality requirements are met

  • Leads support efforts in the establishment of establishing Receiving Acceptance Plan for purchased parts.

  • Leads support efforts in the establishment of measuring and monitoring supplier quality performance per established measures and metrics (KPIs) for part quality

  • A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

  • This job is a fully qualified, career-oriented, journey-level position.

  • Has a complete knowledge of company products and services.

  • 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.

  • Works on issues of diverse scope where analysis of situation or data requires identification and evaluation of a variety of factors, including an understanding of current business trends.

  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.

  • Acts as advisor to subordinates to meet schedules and/or solve technical problems.

  • Develops and administers schedules, performance requirements.

  • Probably has a budget responsibility.

  • responsible for managing a part of a business process or function.

  • Manages the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing.

  • Manages own budget > € 1 M

  • Impact on CoNQ: > € 1M

  • Reports to SQ Manager or Sr. Manager

  • Education

  • 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.

  • 8-10 years of total industry experience with 4+ 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.

  • Experience in root cause analysis, corrective and preventive action methods.

  • Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.

We welcome you to join Philips Ultrasound as an Supplier Quality Engineer in our Reedsville, PA location

In this role, you will be working with our Ultrasound product line Philips Healthcare Ultrasound at http://www.usa.philips.com/healthcare/solutions/ultrasound

You are responsible for

  • Strong knowledge of a production facility “factory”, process engineering, problem solving, manufacturing environment a must.

  • Manage Supplier Quality performance and reporting, GSRS, BRM, QR, Monthly Quality reports (FFOR, Yield, SCAR, etc..), conduct line release for assigned commodities / suppliers

  • Perform supplier QMS and other quality audits as required to confirm supplier compliance to applicable regulatory standards

  • Participate in Supply Base and Commodity Strategy Development

  • Ensures process and quality control plans are in place across the supply chain, alignment of OQC and IQCs SCN point contact for supplier. Liaison between R&D and Supplier as applicable

  • Manage supplier conformance to PQA requirements

  • Drive structural quality and process improvements, such as quality agreements, quality specifications, in collaboration with the commodity managers, R&D and SC Engineering

  • Responsible for, and leads, supplier qualification audits and capability assessments

  • Verify supplier readiness to the appropriate level of maturity, from the quality management perspective, at each milestone in a product development process

  • Ensure supplier early involvement/input into product requirements and design specifications, and supplier participation in Philips design reviews

  • Influence product development (PD) project teams to design for quality/reliability, lead collaboration between the supplier and the PD project team

  • Lead and facilitate implementation of the elements of APQP into new or existing suppliers for NPI projects with suppliers

  • Participate in the assessment, selection and technical development of new (and existing) suppliers

  • Support local factory as assigned, to:

  • Identify quality/technical issues at suppliers, drive resolution (closed loop corrective action, SCAR) with the supplier(s)

  • Execute responsibilities as prescribed in FAI, IQC, SDR, Purge, MRB, SCAR and other SQM/SQE processes

  • Work with other functional engineering disciplines as required to permanently solve technical supplier quality related problems

  • Manage other responsibilities of the SQE role

  • Support introduction of new products into existing suppliers as required for NPI projects

You are a part of

In today’s challenging and changing healthcare environment, clinicians need every image to contribute to a confident diagnosis and every moment to matter in the clinical workflow.

Philips imaging ultrasound machines bring innovative solutions to clinical complexity while simplifying workflow. Our suite of Ultrasound systems Philips Healthcare Ultrasound at http://www.usa.philips.com/healthcare/solutions/ultrasound is designed to meet the many unique challenges – you can make a difference in your new role every day.

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.

  • 8+ years of total industry experience with 4+ 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.

  • Experience in root cause analysis, corrective and preventive action methods.

  • Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc

In return, we offer you

We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people’s lives every day.

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 about the testing process Ultrasound

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 .

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, and 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

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