Quality Assurance Engineer

Job Title: Quality Assurance Engineer

Location: Redmond, WA

Type: Contract

Compensation: $50.00 - $56.66/hr

Contractor Work Model: Hybrid - 4 days/week, 1 remote day, typical hours

Hours: First shift


Hands-on QA Engineer Based role - This is a non-IT based QA position. 

Responsibilities

• Work closely with Operations and the business functions to ensure quality performance of product and processes.
• Collaborate with internal cross-functional and supplier teams to address top quality issues and manage Non-Conformances (NC) and Corrective Action Preventative Action (CAPA) records within TrackWise.
• Support manufacturing complaint investigations and product field actions, including internal non-conforming product disposition within MRB.
• Communicate and collaborate with suppliers regarding non-conformances, escalate Supplier Corrective Action Requests (SCAR), and manage Supplier Initiated Change Requests (SICRs).
• Support manufacturing transfers, execute quality activities, and identify opportunities for supplier part certification.
• Engage in process improvements and validation, including development, review, and qualification of processes and equipment, and maintain KPIs for process and product quality monitoring.
• Perform root cause analysis, lead cross-functional problem-solving, and drive process efficiency and throughput improvements.
• Review validation protocols, reports, change orders, and documentation related to quality systems.
• Support internal and supplier change management activities, including PPAP activities for supplier changes.

Requirements

• Strong root cause analysis experience and investigative skills.
• Ability to lead discussions, influence stakeholders, and work independently or collaboratively.
• Excellent communication skills, especially in explaining resolution plans.
• Experience working in a fast-paced, high-pressure environment with multiple quality issues.
• Experience with validation protocols, reports, and change management.
• Preferred: background in bioscience/lab work, experience in regulated industries, engineering or science degree (BS preferred), familiarity with tools like TrackWise, MasterControl, SAP.
  

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.




System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.




Ref: #558-Scientific