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Redmond, Washington - USD Full Time Posted: Wednesday, 15 November 2017
 
 
JOB RESPONSIBILITIES: Participate in the new product development process by ensuring that all the quality data streams are fully comprehended and that the voice of the customer, as heard through these data streams (complaints, non-conforming records [NCRs], verified failures, etc.), is a design input and consideration. Participate in development of potential hazards associated with new designs through review of predicate products and lessons learned from predicate product lifecycles. Provide subject matter expertise and ownership for Risk Management activities, including, the comprehensive and accurate assessment and characterization of design risks, which includes both the appropriate mitigation activities and proper identification in downstream design outputs (design failure modes and effects analysis [DFMEA], Critical To Quality and Critical To Process characteristics on specifications, Risk Assessments for issues impacting distributed product, etc.). Represent the QA/QE function for the review and approval of designated design outputs. Support the implementation of the Reliability Program for application in new product development and utilization in predictive models for issue characterization. Define the appropriate field performance trending metrics, establishing standardized reporting mechanisms, analyzing results to identify emerging trends and improvement opportunities for production and post-production monitoring of new products after launch. Participate in the CAPA process as task owner/contributor as appropriate and necessary. Provide Quality leadership to drive the timely resolution of quality issues impacting assigned product lines (typically assigned the most complex and/or business critical issue resolution activities). Support material review board (MRB)/non-conforming material processes as needed. Maintain 100% compliance to Quality Management System processes and procedures. May mentor less-senior members of design quality engineering team. Other related duties as assigned. Job Requirements BASIC QUALIFICATIONS: Bachelor s degree in an engineering or technical science, or equivalent combination of education and directly relevant experience 8 years directly relevant experience in research and development or manufacturing, preferably in medical device or other regulated industryPREFERRED/DESIRED QUALIFICATIONS: Advanced degree (MS and/or MBA) Prior experience working with electrical, mechanical, and/or electro-mechanical commodities ASQ certified quality engineer (CQE) and/or black belt certification Excellent verbal and written communication skills Demonstrated ability to work on complex problems with little 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. Demonstrated ability to drive and deliver innovative, effective and timely solutions Demonstrated ability to mentor others in best practices and industry standardsWORKING CONDITIONS: Significant use of standard office equipment, including computer keyboard, monitor, and mouse May require minimal domestic and international travel (

Redmond, Washington, United States of America
IT
USD
Stryker Corporation
Stryker Corporation
JS2365_A760573B6747608FE594737EAC931CD6/299648103
11/15/2017 3:06:35 AM

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