Quality Engineer (ASQ Certified)

Quality Engineer (ASQ Certified)
Bothell, WA
6 months contract to start with (extendable)

Quality Engineer (QE) is responsible in developing and implementing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. Participates in the change management process to assure the products or services continue to meet customer requirements. Participate with cross-functional team with other business and engineering disciplines. Establish the principles of product and service quality evaluation and control for the system. Provide 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. 
 
Responsibilities 
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing client relationships with approval agencies such as the US Federal Drug Administration (FDA). 
 
Key areas of responsibilities (KARS) for this role include: 
•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 
 
Your team 
As a result of renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. 
 
We are looking for: 
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people brand touches each year. 
 
Specific skill requirements for this role include: 
•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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