Our client is currently seeking a Senior Quality Assurance Engineer for an 18 month contract. Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.

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.

• 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. This role requires the candidate to be on site 4 days a week.

MUST HAVES

Strong in critical thinking and "out of the box" thinking Demonstrated ability to work independently and as part of cross-functional teams. Ability to manage multiple tasks simultaneously

NICE TO HAVES

Project management Experience in working in a compliance risk situation Experience in interacting with regulatory agencies Bachelor's of Science degree, strongly preferred in Engineering; minimum of three years preferred