Type:

full-time

Job Description:

Title :

Quality Manager | Medical Device / ISO 13485

Basic Purpose and Function:

The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System (QMS) in accordance with ISO 13485, applicable regulatory requirements, customer requirements, and company objectives. This position serves as the sites management representative for the Quality Management System and ensures that product realization activities, risk management processes, supplier controls, CAPA activities, and post-market quality processes effectively support the manufacture of safe and effective medical devices. The Quality Manager partners closely with Operations, Engineering, Supply Chain, and Customer Service teams to ensure compliance while driving a culture of quality and continuous improvement.

Job Responsibilities:

Quality Management System (QMS) Manage and maintain the

ISO 13485

Quality Management System. Ensure compliance with all applicable regulatory and customer requirements. Oversee document control and record retention processes. Coordinate Management Review activities and present quality system performance metrics. Ensure quality objectives are established, monitored, and achieved. Maintain inspection readiness and audit preparedness. CAPA and Nonconformance Management Lead the Corrective and Preventive Action (CAPA) program. Ensure timely investigation and closure of quality issues. Facilitate root cause investigations Monitor effectiveness of corrective actions. Manage nonconforming product processes and disposition activities. Risk Management Ensure risk management activities comply with

ISO 14971

requirements. Participate in risk assessments associated with products, processes, equipment, and suppliers. Support implementation of risk controls and verification of effectiveness. Ensure risk management files remain current and complete. Validation and Quality Engineering Support Review and approve validation protocols and reports. Support process improvement and process capability initiatives. Ensure manufacturing changes are properly evaluated and validated. Internal Audits and Regulatory Inspections Manage the internal audit program. Coordinate external audits, customer audits, certification audits, and regulatory inspections. Track audit findings through closure. Supplier Quality Management Ensure supplier qualifications and monitoring programs meet

ISO 13485

requirements. Manage supplier audits and supplier performance reviews. Oversee supplier corrective action requests (SCARs). Support supplier risk assessments and change management. Customer Quality and Complaint Handling Manage customer complaint investigations. Ensure complaint handling processes meet applicable regulatory requirements. Analyze customer quality trends and implement improvement actions. Serve as primary escalation point for customer quality issues. Training and Quality Culture Ensure employee training programs meet regulatory and quality requirements. Verify personnel competency for quality-critical tasks. Promote quality awareness throughout the organization. Support continuous improvement initiatives across all departments. Leadership Responsibilities Lead and develop Quality Specialists, Technicians, Auditors, and Inspectors. Establish departmental goals and objectives. Manage department resources. Provide quality guidance to Operations, Engineering, and Customer Service. Success Measures Successful maintenance of

ISO 13485

certification Timely closure and effectiveness of CAPAs Reduction in customer complaints and internal quality issues Successful completion of internal, customer, and certification audits Supplier quality performance improvements On-time completion of Management Reviews and Quality Objectives Required Qualifications, Education/ Experience Bachelor's degree in engineering, Life Sciences, Quality, Manufacturing, or related field required. Minimum 5-7 years of quality management experience in a regulated manufacturing environment. Minimum 3-5 years of experience with

ISO 13485

Quality Management Systems. Experience leading internal and external audits. Experience managing CAPA, complaint handling, and validation activities. Experience working with FDA-regulated or medical device manufacturing environments preferred. Physical Requirements Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing, and repetitive motions. This position frequently requires the use of hands to handle or feel objects, tools, or controls, and to reach with hands and arms. The associate must occasionally lift and/or move up to 40 pounds. 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