More jobs:
Quality Engineer
Job in
Santa Clara, Santa Clara County, California, 95054, USA
Listed on 2026-07-11
Listing for:
Actalent
Full Time
position Listed on 2026-07-11
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Quality Engineer
Job Description
The Quality Engineer independently leads complex quality investigations and drives effective resolution of nonconformances, corrective and preventive actions (CAPAs), and customer complaints. This role plays a key part in maintaining product quality, regulatory compliance, and customer satisfaction through structured problem-solving, technical expertise, and close collaboration with cross-functional teams. The position requires strong experience with quality systems, root cause analysis, risk assessment, and continuous improvement in a regulated manufacturing environment, as well as the ability to influence stakeholders, drive accountability, and enhance quality processes and systems.
Responsibilities
+ Lead end-to-end CAPA activities, including initiation, investigation, root cause analysis, action development, implementation, and effectiveness verification.
+ Apply structured problem-solving methodologies such as 8D, 5 Whys, Fishbone Analysis, and data-driven investigations to resolve quality issues.
+ Develop and implement risk-based corrective and preventive actions that address both immediate and systemic issues.
+ Ensure CAPAs are completed in a timely, compliant, and effective manner with thorough documentation and traceability.
+ Proactively identify investigation risks, quality gaps, or delays and escalate concerns when appropriate.
+ Lead customer complaint investigations of moderate to high complexity and ensure accurate, comprehensive documentation.
+ Coordinate complaint and nonconformance investigation activities with Manufacturing, Engineering, Supplier Quality, Service, and other cross-functional teams.
+ Conduct failure analysis and root cause investigations using returned product evaluations, technical data, and quality records.
+ Ensure complaint handling activities comply with applicable regulatory requirements and internal quality procedures.
+ Connect complaint findings to internal nonconformances and CAPAs to maintain a robust closed-loop quality system.
+ Analyze complaint trends and identify recurring product or process issues that require corrective action.
+ Serve as the quality lead on investigation teams, driving accountability and timely resolution of quality issues.
+ Support product containment activities, including risk assessments, product holds, and impact evaluations.
+ Partner with Supplier Quality to address supplier-related quality issues and manage Supplier Corrective Action Requests (SCARs).
+ Provide technical expertise during audits, regulatory inspections, and quality system reviews.
+ Contribute to the development, maintenance, and continuous improvement of quality procedures, work instructions, and business processes.
+ Perform data analysis across nonconformances, CAPAs, complaints, and quality metrics to identify trends and improvement opportunities.
+ Lead or support continuous improvement projects using Lean, Six Sigma, PPI, or similar methodologies.
+ Recommend and implement improvements to investigation effectiveness, cycle time reduction, and overall quality system performance.
+ Develop and maintain quality metrics, dashboards, and reporting tools to monitor process performance.
+ Provide guidance and informal mentorship to team members on investigation techniques and root cause analysis best practices.
+ Promote consistent application of quality principles and structured problem-solving methodologies across the organization.
+ Support a culture of continuous improvement, compliance, and operational excellence.
+ Handle complaint backlog through effective NCR and CAPA execution in alignment with quality management system requirements.
Essential Skills
+ Bachelor's degree in Engineering or a related technical discipline.
+ 1-3 years of Quality Engineering experience within a regulated industry.
+ Experience working under cGMP, ISO 9001, ISO-based or similar quality management systems.
+ Proven experience leading nonconformance investigations, CAPAs, and customer complaint handling activities.
+ Demonstrated ability to work cross-functionally with Manufacturing, R&D, Operations, and Supplier Quality teams.
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Experience with fail…
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