Medical Device Client is seeking a Quality Assurance Engineer for a18 month contract in Redmond, WA!




Senior Quality Assurance Engineer - Onsite




Pay Rate Range: $33.33/hr. - $46.66/hr.



Description/Comment:




Key Areas of Responsibility:



* Work closely with Operations and the business functions to ensure quality performance of product and processes.


* Non-Conformances


o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.


o 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.


o Support execution and analysis of manufacturing related complaint investigations and product field actions.


o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.


* Supplier Activities


o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.


o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval


o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.


o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.


Own PPAPs, for supplier changes,


* Process Improvements/Validation


o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.


o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.


o Participate in and potentially lead the creation and/or review of new or modified procedures.


o Support the development and review of process and equipment validation/qualification and MSA of internal processes.


o 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.


All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.