Quality Manager

We are seeking an experienced and detail-oriented Quality Manager to lead the quality assurance and quality control functions at our high-tech manufacturing facility. The successful candidate will be responsible for maintaining and improving the Quality Management System (QMS) in accordance with ISO 9001 and ISO 13485 standards, ensuring compliance with all applicable regulatory and customer requirements. This role requires strong leadership, analytical, and communication skills, as well as hands-on experience in a technology or electronics manufacturing environment.

Roles & Responsibilities

• 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.
• o Provide quality training to cross-functional teams.
• Other job duties as assigned

Education & Experience

Knowledge, Skills, & Abilities