Job Title: Quality Engineer III
Location: Santa Clara, CA 95054
Duration: 6 months W2 contract with high possibility of extension based on performance and depending on business needs
Pay Range: $40 to $45/Hour on W2
Position Summary:
This candidate will work closely with cross functional teams to write, edit, review and finalize technical documents to support design transfer activities.
The individual will write or process and implement all quality documents related to design transfer activities including procedure change orders and document change orders to reflect approved changes.
Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented.
How will you make an impact?
As a quality engineer iii, you will independently lead complex quality investigations and drive resolution of nonconformances, capas, and customer complaints. You will act as a key contributor to ensuring product quality, regulatory compliance, and customer satisfaction by applying strong technical judgment, structured problem-solving, and cross-functional collaboration. You will also help strengthen quality processes through data analysis and continuous improvement initiatives.
What will you do?
Corrective And Preventative Actions
Own end-to-end CAPA activities for assigned issues, including initiation, investigation, root cause analysis, action definition, and effectiveness verification.
Apply structured root cause analysis methodologies (8d, 5 whys, fishbone, data analysis) to ensure robust problem-solving.
Develop practical, risk-based corrective and preventive actions that address systemic issues.
Ensure CAPAS are timely, compliant, and effective, with clear documentation and traceability.
Identify gaps in CAPA quality or delays and proactively escalate risks to management.
Customer Complaint Investigations
lead customer complaint investigations of moderate to high complexity, including coordination with manufacturing, engineering, service, and supplier teams.
conduct failure analysis and root cause determination using available data, returned product evaluation, and technical expertise.
ensure complaints are handled in accordance with regulatory and internal requirements, including proper documentation and closure timelines.
link complaint findings to internal nonconformances and capas to ensure closed-loop quality.
analyze complaint trends and support identification of systemic product or process issues.
Cross-Functional Quality Leadership
Act as a quality lead on investigation teams, driving accountability and timely resolution across functions.
Support product containment decisions, including risk assessments, product holds, and impact evaluations.
Collaborate with supplier quality to address supplier-related nonconformances and scars.
Provide technical input during audits, inspections, and quality reviews.
Support development and improvement of procedures, work instructions, and quality system processes.
Data Analysis & Continuous Improvement
Perform data-driven analysis across NCM, CAPA, and complaints to identify trends and improvement opportunities.
Lead or contribute to continuous improvement initiatives using lean, ppi, or six sigma methodologies.
Recommend and help implement improvements to investigation quality, cycle time, and process effectiveness.
Support development of quality metrics and dashboards for monitoring performance.
Capability Building
Provide guidance and informal mentorship to team members on rca and investigation best practices.
Promote consistent use of structured problem-solving tools and quality principles across teams.
How Will You Get Here?
Education
Bachelor s degree in Engineering or related technical discipline required.
Experience
5–8 years of quality engineering experience, preferably in regulated industries (cGMP, ISO 9001/13485).
Demonstrated experience leading nonconformance investigations, CAPAs, and customer complaint handling.
Experience working cross-functionally with Manufacturing, R&D, and Supplier Quality.
Familiarity with failure analysis, and risk-based decision making.
Knowledge, Skills & Abilities
Strong knowledge of quality systems, regulatory requirements, and investigation processes
Proficient in root cause analysis and structured problem-solving methodologies
Ability to independently manage multiple complex investigations
Strong analytical and data-driven decision-making skills
Effective communication and ability to influence cross-functional teams
Detail-oriented with strong technical documentation skills
Physical Requirements
Ability to work onsite in both office and manufacturing environments.
Ability to lift up to 35 lbs occasionally.
Ability to work at a computer for extended periods (up to 8 hours/day).