SIMONA MALLOY

· Supported and continuously improved the site's Quality Management System (QMS) to ensure compliance with customer-specific requirements and ISO 9001/IATF 16949 quality standards.

· Lead root cause investigations utilizing 5 Whys, Fishbone Analysis, 8D and statistical methodologies to identify, contain, and eliminate recurring quality issues.

· Managed CAPA activities from initiation through effectiveness verification, ensuring implementation of sustainable corrective actions and minimizing quality risks.

· Facilitated nonconformance management processes, overseeing containment, investigation, disposition, corrective action implementation, and verification to enhance overall quality compliance.

· Conducted internal audits, process audits, and compliance assessments to ensure adherence to quality system requirements and identify continuous improvement opportunities.

· Collaborated with Manufacturing, Engineering, Supply Chain, and Operations teams to improve process capability, product quality, and customer satisfaction.

· Supported customer complaint investigations and corrective action activities, improving responsiveness and reinforcing product quality and customer confidence.

· Provided quality training and coaching to production teams, driving ownership, accountability, and a culture of quality.

· Lead Lean Six Sigma initiatives focused on defect prevention, waste reduction, process optimization, and operational excellence.

Key Contributions

• Successfully led multiple CAPA and root cause investigations that improved process reliability and reduced recurring quality issues.
• Enhanced audit readiness through proactive compliance assessments, process standardization, and improved documentation control.
• Improved cross-functional collaboration among Quality, Manufacturing, Engineering and Supply Chain teams, accelerating issue resolution and corrective action implementation.
• Strengthened QMS effectiveness through audit support activities, and document management practices.

• Directed manufacturing operations within a 24/7 automotive coatings production environment while maintaining compliance with safety, quality, and customer requirements.
• Monitored KPIs and operational metrics to improve quality performance, productivity, and process consistency.
• Supported QMS initiatives through process control, standard work compliance, and employee training to drive continuous improvement.
• Partnered with Quality and Engineering teams to investigate production and quality issues using structured problem-solving methodologies.

Selected Achievements

• Improved operational performance through process standardization and workforce development initiatives.
• Enhanced collaboration among Production, Quality, Engineering, and Supply Chain functions.
• Improved response times and corrective action execution through cross-functional problem solving.
• Increased process consistency through training, coaching, and adherence to standard work practices.

• Led product development and commercialization activities from concept through manufacturing implementation.
• Led commercialization efforts for 8 successful product launches.
• Managed technical investigations and root cause analyses, resolving quality, formulation, and manufacturing challenges to support product reliability.

Selected Achievements

• Generated multi-million-dollar cost savings through formulation optimization and manufacturing process improvements.
• Achieved EPA approval and production readiness for a critical product by resolving compliance and formulation challenges.
• Applied DOE and statistical analysis techniques to optimize product performance and process reliability.

Selected Achievement

• Developed a primer product line generating approximately $2.8 million in annual revenue and securing new business with Honda.
• Led product development projects for automotive coatings, enhancing application performance and manufacturing efficiency.
• Conducted product testing and DOE studies, providing technical analysis and troubleshooting to optimize process evaluations.
• Supported manufacturing process improvements and implemented new products to streamline operations.