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.