Quality Engineer III

Primary

Skills:

Root Cause Analysis (advanced), ISO 13485 (advanced), CAPA Management (advanced), Customer Complaint Handling (advanced), Data Analysis (advanced)

Contract Type: W2 Duration: 6 Months

Location:

Santa Clara, CA - 95054 (#LI - Onsite) Pay Range: $40/hr - $45/hr Travel: 10% #LP

This role focuses on independently leading complex quality investigations and driving the resolution of nonconformances and customer complaints. The Senior Quality Engineer will play a crucial part in ensuring product quality and regulatory compliance through strong technical judgment and cross-functional collaboration. They will also contribute to strengthening quality processes through data analysis and continuous improvement initiatives.

Lead end-to-end CAPA activities, including investigation, root cause analysis, and effectiveness verification. Investigate customer complaints, coordinating with various teams for failure analysis and root cause determination. Serve as a quality lead on cross-functional teams, driving accountability and timely issue resolution. Analyze data from nonconformances, CAPAs, and complaints to identify trends and improvement opportunities. Provide guidance and mentorship on investigation best practices to team members.

Proven experience leading nonconformance investigations and CAPAs. Strong understanding of quality systems and regulatory requirements. Proficiency in root cause analysis and structured problem-solving methodologies. Experience in regulated industries such as in vitro diagnostics (IVD) or medical devices, with a strong understanding of relevant quality standards like ISO 13485 and FDA QSRs, is highly preferred.