Senior Quality Assurance Engineer Jobs in USA, WA, Redmond | Rose International Job

Required Education:

• Bachelor's degree in Engineering, Science, or a related field

Required Qualifications:

• Strong experience in root cause analysis and problem-solving
• Experience handling Non-Conformances (NC) and CAPA processes
• Ability to work in a fast-paced, high-pressure manufacturing environment
• Strong communication skills and ability to influence cross-functional stakeholders
• Ability to work both independently and collaboratively
• Experience interacting with manufacturing, engineering, regulatory, and suppliers
• Ability to manage multiple priorities and pivot quickly
• Experience with quality systems and documentation review
• Familiarity with tools/systems such as: oTrackWise (NC, CAPA, complaints) oMasterControl (document management) oSAP (manufacturing/order management)

Preferred Qualifications:

• Experience in the medical device industry or other regulated industries
• Experience working on a manufacturing floor
• Knowledge of quality tools and methodologies: oPPAP (Production Part Approval Process) o

DFMEA / PFMEA

• Experience with process validation and equipment qualification
• Background in bioscience, lab work, or technical environments
• Strong stakeholder management and execution skills

Key Responsibilities:

• Collaborate with operations and business functions to ensure product and process quality
• Investigate and manage non-conformances (NCs) and CAPAs, ensuring timely closure
• Lead root cause analysis and cross-functional problem-solving efforts
• Handle MRB activities, including disposition of non-conforming products
• Support complaint investigations and product field actions
• Work closely with suppliers:
• Drive process improvements and manufacturing efficiency initiatives
• Support and review: Validation protocols and reports, Process and equipment validation, and Change orders and documentation
• Own and execute PPAP activities for supplier changes
• Maintain and analyze KPIs to monitor product/process quality and identify trends
• Participate in the development and review of procedures and quality systems
• Support manufacturing transfers between plants/facilities
• Act as a universal Quality Engineer, adapting daily tasks based on business needs
• Provide rapid response and direction during line-down or critical production issues
• Only those lawfully authorized to work in the designated country associated with the position will be considered.
• Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.