Sr Supplier Quality Engineer (Redmond)

Oct. 24, 2011

Seattle, WA

Confidential

Physio-Control is seeking a Sr Supplier Quality Engineer.

For more than 55 years Physio-Control, Inc., maker of renowned LIFEPAK{R} defibrillators, has been developing technologies and designing devices that are legendary among first response professionals, clinical care providers and citizens everywhere. Our defibrillators set the standard upon which an entire industry was built. From the beginning, our product development was customer-driven. It still is.

We are looking for talented and driven individuals to help us advance our Vision: A society in which no person dies suddenly as a result of a cardiorespiratory event.

If you would like to join in our important work, please check out our website: http://www.physio-control.com/about/careers/

Sr Supplier Quality Engineer:79320

Position Description:

Manage all aspects of tier one and sub-tier supplier quality activities for assigned suppliers/ commodities; drive quality and process improvement at assigned suppliers/commodities. Assess, monitor, and ensure the continued adequacy and effectiveness of the quality system for the assigned supplier base. Support supplier selection, supplier process validation/controls, general supplier development. Review and approve inspection sampling plans for selection parts.

Position Responsibilities:

Ensure the proper validation of supplier processes and test methods and the product/process change management process.

Manage first article inspection process along with measurement system analysis (MSA), component qualification, and process validation including Physio-Control manufacturing process verification if required.

Own and maintain supplier part control plans (SPCPs).

Approve supplier manufacturing/test/inspection plans and procedures; perform periodic supplier audits and risk assessments as well as support new supplier development and commodity team strategies.

Work closely with tier one suppliers to sustain and improve component quality. Impose supplier product/process change management process.

Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records.

Support new supplier development and commodity team strategies.

Participate in design reviews with the development teams.

Automate supplier data collection and reporting; support any score carding activities.

Apply sound quality principles such as six sigma, lean, and statistical process control, to drive internal and supplier quality and process improvement.

implement real-time work in process (WIP) and failure tracking process at supplier sites.

Establish component level ongoing reliability testing (ORT) at factory and drive quality improvement if required.

Correlate and standardize test and inspection processes as required.

Drive failure analysis and corrective actions/supplier corrective action requests (SCAR) within assigned suppliers/commodities.

Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures.

Maintain 100% compliance to Physio-Control processes and procedures.

May participate in definition of critical-to-quality/process/function parameters for critical components/sub-systems.

Other related duties as assigned.

Basic Qualifications:

Bachelor's degree in an engineering or technical science, or equivalent combination of education and directly relevant experience

5 years' directly relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment

Desired/Preferred Qualifications:

8+ years' of directly relevant experience

Advanced degree (MS and/or MBA)

Prior experience working with electrical, mechanical, and/or electro-mechanical commodities

ASQ certified quality auditor (CQA) and/or green belt certification

Excellent verbal and written communication skills

Ability to work with minor guidance and under pressure

Must be a team player

General statistical quality tools knowledge with process capability; demonstrated ability to apply six sigma and statistical quality control methodologies

Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.

Lead ISO Auditor certification

Demonstrated ability to drive and deliver innovative, effective and timely solutions

Physical Job Requirements:

Significant use of standard office equipment, including computer keyboard, monitor, and mouse

Domestic and international travel (20-40%)

Ability to lift up to 35 pounds

Physio-Control, Inc., a division of Medtronic, is dedicated to the total well-being of our employees and have been recognized for eight of the last ten years by Fortune magazine as one of the "100 Best Companies to Work For."