Manager

• Maintain and continuously improve the company’s QMS in compliance with ISO 9001 and ISO 13485 standards.
• Ensure that quality objectives are established, tracked, and met across departments.
• Lead internal audits and manage external audits by customers, registrars, and regulatory agencies.
• Oversee document control, CAPA, non-conformance, and risk management processes.
• Ensure compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820 for medical devices).
• Manage regulatory inspections and certification audits.
• Develop and enforce procedures and policies that support compliance.
• Drive root cause analysis and implement effective corrective/preventive actions (CAPA).
• Work closely with Engineering, Production, and Supply Chain to ensure product quality from design to shipment.
• Manage incoming, in-process, and final inspection processes.
• Lead initiatives to reduce scrap, rework, and returns.
• Develop and maintain supplier quality performance metrics.
• Conduct supplier audits and qualification.
• Collaborate with suppliers to resolve quality issues and drive continuous improvement.
• Lead and develop the Quality Team, including QA Engineers, Technicians, and Inspectors.
• Foster a culture of quality, compliance, and continuous improvement across the organization.
• Provide quality training to cross-functional teams.
• Other job duties as assigned

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