Haresh Paghadal

Quality Manager @Accumax Lab Devices Pvt Ltd

Gandhinagar, IN

Implement and maintain Quality Systems in alignment with ISO 9001, ISO 13485, ISO 14001, ISO 45001and other regulatory standards.* Lead and manage the Quality team across QA, QC, and IPQA functions for equipment and consumables manufacturing.* Lead internal audits of QA and QC departments to assess documentation adequacy, technical compliance, and effectiveness of CAPA.* Represent the organization during customer audits, third-party assessments, and regulatory inspections.* Ensure Class 7 cleanroom compliance, monitor environmental controls, and oversee routine internal audits to maintain sterility and regulatory readiness.* Manage CAPA and customer complaint systems, ensuring timely investigation, root cause analysis, and effective closure of action items.* Analyze quality data to identify trends, drive corrective measures, and support PDCA-based continuous improvement initiatives.* Provide quality inputs during Product & Vendor Development, Process Control, Customer Quality Assurance, and New Product Development stages.* Drive monthly Management Review Meetings (MRMs) to monitor key quality metrics and define strategic improvements.* Lead and conduct training programs for shop floor teams and subordinates, ensuring quality awareness and compliance.* Maintain technical data, product documentation, and version control in accordance with internal and customer-specific requirements.* Champion system excellence in 5S, ISO, KAIZEN and EHS practices.* Focus on reducing Cost of Quality while improving operational reliability and customer satisfaction.