Philips Supplier Quality Engineer in Colorado Springs, Colorado

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 Posting Description

In this role, you have the opportunity to

improve sourcing support of our New Product Development (NPD) function by developing and leading robust sourcing processes that drive selection of the best suppliers based on all technical, quality and business (including cost) requirements throughout the product lifecycle.

You are responsible for

  • Lead the supplier selection, approval, classification, and development through a combination of audits and product or process qualifications.

  • Act as liaison between Philips and supplier for New Product Development

  • Collaborate with suppliers in defining supplied material specifications, identifying critical component features and supplier manufacturing processes, developing and validating supplier manufacturing processes, and implementing appropriate process controls and monitoring

  • Assist suppliers with the development and implementation of statistical sampling plans and inspection procedures.

  • Monitor, review, and report on supplier performance, in-house and to the supplier. Initiate corrective action

  • Lead sourcing efforts in New Product Development as the focal

  • Perform failure investigations in order to determine the root cause of supplied material failures. Recommend, implement and follow-up on corrective/preventative actions.

  • Serve as technical resource for process improvement projects such as alternative measurement/testing methodologies, supplier supplied data, and Master Lot qualification programs.

  • Assist in resolving internal and external audit findings and observations in Receiving Inspection. Develop and implement corrective actions

  • Serve as a Subject Matter Expert on the Material Review Board to determine the appropriate disposition and required corrective action of discrepant material during New Product Development

  • Ensure regulatory compliance in production processes with FDA QSR and ISO 13485:2003 regulatory requirements.

  • Responsible for supplier quality documentation review and control in the Spectranetics Document Control system

  • Lead CAPA teams through root cause investigations to implementation and final verification

  • Must be able to interface well with others

You are a part of

Our dynamic sourcing team that supports our suppliers, Purchasing, Supplier Quality Engineering and the NPD project teams.

To succeed in this role, you should have the following skills and experience

  • BS, Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline preferred

  • ASQ Certified Quality Engineer a plus

  • Green Belt or Black Belt certification in Six Sigma / Lean Sigma a strong plus

  • Supplier Management Engineering position in a medical device (Class II & III) or similar environment desirable, not required

  • Proven project management skills in a technical environment

  • Ability to lead technical teams including engineering and scientific personnel

  • Proficient with geometric tolerance specifications

  • Development of Go/No-Go gauges

  • Evaluation of measurement system capabilities and biases

  • Process qualification and validation

  • Non-conforming Materials / MRB participation experience required. Leadership of MRB is a plus.

  • 3 Years specific engineering experience (medical device preferred)

  • Good understanding & experience in advanced problem solving including statistical techniques

  • 3 Years’ experience in application and leading problem-solving, root cause analysis and related Corrective and Preventive Actions (including verification)(CAPA)

  • CAPA (Define / Implement / Verify CAPA plans) leadership

  • Sound understanding of quality concepts, regulatory compliance requirements and tools including ISO 13485:2003 and the FDA QSR

  • Must be able to read blueprints and diagrams.

  • Proficient in technical mathematics and statistical process control

  • Must be computer proficient (Microsoft Office Suite required). Ms-Project, Mini-Tab or JMP (statistics) and Visio (flowcharting) experience a plus.

  • Proven ability to lead (influence) in a cross-departmental technical environment

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.

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, 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.