Product Design Quality Engineer

job summary:
Our client, a leader in the medical manufacturing industry is looking for a Product Design Quality Engineer for their Bothell, WA location. Key qualifications include, 5+ years of experience in design controls, gap analysis,traceability, and risk management with experience in integrated medical devices. 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 & Transfer: Manages the entire design control process, validating critical inputs (usability, safety, reliability) and executing statistical process validation strategies for smooth transfer to production.

• Risk Management & CAPA: Guides lifecycle risk management and executes the full CAPA process-from root cause analysis to implementing solutions that prevent defect recurrence.

• Documentation & Audit Readiness: Oversees quality engineering documentation (hardware, software, and systems) to guarantee compliance and maintain ongoing readiness for internal and external audits.

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

• Cross-Functional Leadership: Works under limited supervision to mentor, guide, and collaborate with internal and external stakeholders to align with quality standards and project milestones

qualifications:

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

 
skills:

• Product Design
• Product Design
• Product Design
  
  
  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.