CAPA Quality Engineer
We are looking for a CAPA Quality Engineer in Bothell, WA
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.
We are looking for:
A person who has strong technical competencies, and demonstrates resilience in 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 our brand touches each year.
location: Bothell, Washington
job type: Contract
salary: $80 - 90 per hour
work hours: 8 to 5
Key areas of responsibilities (KARS) for this role include:
- 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
skills: Furthermore to be successful in this role you are:
- Motivated, self-driven with a determination to succeed and the ability to manage change.
- Analytical, you are open to new ideas and believe in continuous learning in order to develop new competencies.
- Fluent in English
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.