Sr. Supplier Quality Engineer
- Plymouth, MN
Sr. Supplier Quality Engineer
In this role, you have the opportunity to
Provide sustaining SQE activities in managing daily NCR's, SCAR's, SCN's, SQIP's, and managing the ASL. Manage APQP with selected suppliers.
You are responsible for
- Responsible for managing the Approved Supplier List (ASL).
- Working knowledge and understanding of the software Agile, Windchill and Trackwise.
- Working with various departments in addressing and dispositioning of non-conformances from investigation to resolutions.
- Performing data analysis and reporting for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control's. When required, assists the SQE Team in supporting supplier audits and supplier qualification. Knowledge or experience with CPK, APQP, MSA, FMEA, Process Capability Statistics in relation to Six Sigma which is essentially process optimization, understands QSIT, serve as a Quality interface to suppliers supporting quality and productivity goals, proactively monitoring and measuring product/process quality and performance trends, and troubleshooting of production/release issues is a plus.
- Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes.
- Drive supplier improvement via SQIP (Supplier Quality Improvement Plans)
- Lead Supplier Change Notice process with support from Engineering, Quality Engineering / Assurance, Regulatory, ME, R & D, Clinical, etc.
You are part of
the local Supplier Quality organization who reports into a local SQE Manager that will support the local production facility. The SQE organization assists in NPI, Procurement, Sustaining and Quality initiatives as well as Supplier Quality improvements. The SQE team is divided into NPI / Procurement initiatives and Sustaining. In some cases these can and will overlap to help support the team member(s) and projects.
To succeed in this role, you should have the following skills and experience
- Bachelor's /Master's degree in Engineering, preferred.
- 5 years of total industry experience 4+ years of related experience in a medical device or regulated industry.
- Direct working relationships with suppliers
- Experience with NPI from start to finish along with direct shop-floor production engineering sustaining 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 is preferred.
- Preferred 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.
- Good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.)
In return, we offer you
Enjoy endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare and allow you to create your own legacy.
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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
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