Senior QA Engineer

Overview

Job Title: Senior Engineer, Quality Assurance Engineering

Location: Redmond, WA

Hours/

Schedule:

7:30 AM–5/6 PM

Compensation: $56.66- $66.33/hr

Type: Contract

• Work closely with Operations and the business functions to ensure quality performance of product and processes.
• Non-Conformances: own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action (CAPA) records, managing timely processing and closure of NC and CAPA within the electronic management system (Trackwise).
• Collaborate with internal cross-functional and supplier teams to address top quality issues.
• Support execution and analysis of manufacturing related complaint investigations and product field actions.
• Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
• Supplier
  
  Activities:
  
  communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
• Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
• Process Improvements/Validation: engage in the development and improvement of internal manufacturing and distribution processes for existing products.
• Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including PPAP activities for supplier changes.
• Participate in and potentially lead the creation and/or review of new or modified procedures.
• Support the development and review of process and equipment validation/qualification and MSA of internal processes.
• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary.
• Perform other related duties as assigned.

• Investigating nonconformances, CAPAs, and quality issues
• Performing root cause analysis
• Leading cross-functional problem-solving huddles
• Driving process improvements (efficiency, throughput, new equipment). This is a fast-paced, high-pressure environment where multiple quality issues can arise; the QE must be able to pivot quickly, provide direction, and help get production back up and running.
• Naturally curious and investigative
• Strong root cause analysis experience
• Comfortable leading discussions and influencing stakeholders
• Able to work independently and collaboratively
• Strong communication skills, especially when explaining resolution plans
• Comfortable working in stressful, time-sensitive situations

• Manufacturing operators (on the line and at their desk)
• Engineering
• Regulatory
• Compliance
• Suppliers

Experience on a manufacturing floor is highly desirable (but not required).

• Review and/or support validation protocols and reports
• Process and equipment validation
• Label reviews
• Change orders
• Documentation reviews

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.