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