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
Job Summary: 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.
Key Responsibilities:
- 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.
Must-Have Skills:
- 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.
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