Job Details
Job Id:
Supplier Quality Engineer
Job Type:
Bothell WA 
Perform quality engineering and quality system related tasks to support the design, development, and production of disposable and durable medical device systems, including software. Manage Receiving Inspection (RI) department, including supervision of Receiving Inspectors, development of inspection methodologies and selection of inspection equipment.

Responsibilities include, but are not limited to:
Participate in the activities related to Supplier Management for materials, components, parts, subassemblies and services that are used in the manufacture of products or to support the manufacturing process.
Support activities required for evaluation, assessment, and approval of contractors, service providers, and suppliers.
Support and participate in the audits of contractors, service providers, and suppliers.
Provide quality engineering input to any project proposals involving new suppliers or new components / materials.
Participate in the creation and review of Supplier Quality Agreements.
Provide quality engineering support to evaluate any proposed supplier process and component changes for approval.
Provide supplier quality support to suppliers including evaluation of first article inspections and formation of statistical sampling plans, inspection methodology, and procedures.
Review incoming material rejections and determine appropriate corrective actions.
Drive Supplier Corrective Actions (SCAPAs) to closure to address supplier issues identified.
Initiate improvements to the Supplier Management Systems, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
Participate as key Material Review Board (MRB) member to resolve Nonconforming Material Reports (NCRs) in a timely manner and minimize impact to production. Conduct nonconforming material investigations and dispositions as required.
Manage Receiving Inspection area and Receiving Inspectors. Aid in determining inspection requirements, designing inspection/test fixtures, and purchasing inspection equipment.
Perform or coordinate failure investigations and prepare failure investigation reports.
Recommend, plan and lead assigned corrective and preventive actions for continuous improvement.
Prepare and analyze quality metrics as needed for Quality Management Reviews or as deemed necessary to assist in identification of failure trends.
Participate in the creation, implementation, and teaching of new or improved quality system processes. Write procedures and instructions, as required.
Write, review and approve specifications, test protocols, and reports, as needed.
Support other departmental activities as requested by department management or designate.

BS degree in Engineering or equivalent degree/experience
Minimum three (3) years supplier quality engineering experience in the manufacturing industry, of which one (1) year should be in the medical device industry.
Excellent verbal and written skills, proficient user of MS/ Office programs.
Basic metrology expertise required.
Familiarity with GD&T best practices desirable.
Proven supplier development, negotiation and interface experience
Sound problem-solving skills and analytical capabilities in a highly dynamic, fast paced environment
Exceptional leadership skills with a hands-on, team oriented approach
Ability to travel up to 30% time, 10% internationally
Direct experience with FDA QSR, GMP, MDD & ISO 13485 compliance for the development, validation and manufacture of disposable and durable medical devices, including software.
Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Black Belt (CSSBB) status desired.