A.C. Coy

Quality Engineer

US-WA-Bothell
4 weeks ago
Job ID
2017-17497
# of Openings
1
Category
Information Technology

Overview

Our client, a leader in the health care industry, is actively seeking a Quality Engineer for an 11 month contract in the Bothell, WA area. The Quality Engineer will be responsible in developing and implementing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations.

Responsibilities

  • Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design 
  • Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs 
  • Provides effective oversight of the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle 
  • Performs independent technical assessment on product quality performance and post-market product quality analysis 
  • Can Lead quality related problem solving and root cause analysis during design and manufacturing
  • Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required 
  • Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone 
  • Provide leadership and oversight to ensure Quality Management System Compliance 

Qualifications

  • ASQ certified Quality Engineer 
  • Engineering Degree or equivalent experience in medical device industry 
  • 5+ years experience with a medical device company 
  • Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics. 
  • Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements. 
  • Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up. 
  • Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving. 
  • Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems

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