Quality Engineer

Quality Engineer

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.

• 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.

• 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.
• Experience with failure analysis, risk assessment, and data-driven decision-making.
• Strong understanding of quality systems, regulatory requirements, and investigation processes.
• Proficiency with root cause analysis and structured problem-solving methodologies such as 8D, 5 Whys, and Fishbone Analysis.
• Ability to independently manage multiple complex investigations and competing priorities.
• Excellent analytical, critical-thinking, and decision-making skills.
• Strong written and verbal communication skills with the ability to influence cross-functional stakeholders.
• Detail-oriented approach with excellent technical documentation and report-writing abilities.
• Hands-on experience with quality management systems (QMS), CAPA, NCR, and complaint handling.
• Experience using Track Wise or similar quality management software.

• Experience with continuous improvement tools and methodologies such as Lean, Six…