Quality Manager

Job description

Position Summary The Quality Manager is responsible for the development, implementation, and continuous improvement of the site’s Quality Management System (QMS). This role ensures compliance with ISO standards, regulatory requirements, customer expectations, and internal policies. The Quality Manager serves as the primary site representative during external audits (ISO, FDA, RBA, NAID, R2, customer audits) and is accountable for audit readiness at all times. This position holds authority to escalate compliance and quality risks and to stop production or distribution activities when necessary to protect the company and its customers. Key Responsibilities: Quality Management System Ownership: - Maintain and improve the site’s ISO-compliant Quality Management System (ISO 9001, 14001, 45001 and others as applicable) - Ensure policies, procedures, and work instructions remain current and controlled - Oversee document control and revision processes - Ensure alignment between documented procedures and operational execution - Conduct management review preparation and reporting Audit & Regulatory Leadership: - Lead internal audit program and risk-based audit planning - Serve as primary hos...