CAPA/Quality Engineer

Location: Bothell WA
Duration: 9 Months + Extendable
The CAPA/Quality Engineer (QE) is responsible in developing and implementing systems to ensure products are designed and produced to meet customer requirements and expectations. He/she drives the strategy and approach of the CAPA team to establish the root cause in a systematic way and coordinates the use of adequate tools and methods. Provides direction for the cross-functional team with other business and engineering disciplines to follow a structured problem solving approach. Establishes the principles of product and service quality evaluation and control for the system. Provides independent oversight and review of the project deliverables throughout the product lifecycle. Provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same. 
 Provide leadership and oversight to ensure effective CAPA solving and closure with a cross-functional team 
 Ensures that appropriate quality plans are made that include all stages of the CAPA process 
 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 
 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 
 Specific skill requirements for this role include: 
 ASQ certified Quality Engineer or DfSS/DMAIC Black Belt (or equal by experience) 
 Engineering Degree or equivalent experience in medical device industry 
 5+ years experience with a medical device company 
 Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements. 
 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 system 
 Use established Business Excellence methodologies such as DfSS, DMAIC, Statistical Engineering (Shainin tools), PDCA, SPC, 8D ... 
 Provide data driven expert opinion on root cause analysis of failure modes 
 Experience in manufacturing quality control and improvement programs is highly preferred. 
 You combine analytical and conceptual thinking, physical insight, flexibility and a hands-on mentality to deliver sustainable results and creative solutions. 
 Excellent reporting and documentation skills 
 Experience with working with quality and reliability tools and templates, e.g. Minitab, JMP, Reliasoft, FMEA, FTA, HAZOP, … 
 Excellent consultancy skills, a team player with the ability to connect with business stakeholders 
 Good project management skills 


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