Senior Quality Assurance Engineer

Job Title: Senior Quality Assurance Engineer
Location: Redmond, WA
Hours/Schedule: 8am-5pm, Mon- Fri
Compensation: $36.66- $46.50
Type: Contract
 
Overview
Global Medical Device company looking to hire experienced QA Engineer to their team.  Looking for 2-4 year's of experience and must bring a BS Degree in Engineering.  This is not an IT role!
 
Responsibilities

• Work closely with Operations and the business functions to ensure quality performance of product and processes.
• Non-Conformances
• Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
• Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
• 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 & 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 the internal manufacturing and distribution processes for existing products.
• Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (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 on appropriate actions as necessary.
• Perform other related duties as assigned.  
  Requirements
  • BS Degree
  • 2-4 year's experience 
  • Multi-tasking, strong communication, problem solving
  
  Benefits
  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.

Salary : $37 - $47