Systems Design Quality Engineer

job summary:
Our client, a leader in the medical manufacturing industry is looking for a Systems Design Quality Engineer for their Bothell, WA location. Key qualifications include, 5+ years of experience in new product development environments, understands regulatory requirements, and can support multiple projects while partnering closely with cross-functional teams. Experience in integrated medical devices is preferred. A Bachelor's degree in a relevant field is required.

location: Bothell, Washington
job type: Contract
salary: $55 - 56 per hour
work hours: 8am to 4pm
education: Bachelors

responsibilities:

• Design Control & Validation: Leads end-to-end design controls-from validating inputs (usability, safety, reliability) to managing verification, validation, and transfer into production using statistical process tools.

• Risk Management & CAPA: Drives risk management activities across the product lifecycle and manages the CAPA process through root-cause analysis and corrective actions.

• Documentation & Compliance: Oversees quality engineering documentation (hardware, software, systems) and maintains continuous audit and inspection readiness for regulatory standards.

• Post-Market Surveillance & Continuous Improvement: Integrates post-market performance data and PMS insights into manufacturing and design to fuel product reliability and quality improvements.

• Stakeholder Mentorship & Autonomy: Works under limited supervision while guiding, mentoring, and building relationships with internal and external stakeholders to meet project milestones.

qualifications:

• Experience level: Experienced
• Minimum 5 years of experience
• Education: Bachelors

 
skills:

• Quality
• Quality
• Professional Engineer
  
  
  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.
  At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.
  
  
  Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
  
  
  This posting is open for thirty (30) days.