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System.  \nQUALITY SYSTEM:  \n§ Develop, implement, communicate, maintain and improve the Company’s Quality Systems to establish compliance with ISO13485 requirements.  \n§ Ensure compliance with relevant standards and legislation.  \n§ Maintain up-to-date quality system records  \n§ Support all functional areas in their efforts to develop written procedures appropriate to their needs  \n§ Work with Top Management for process control and improvements  \nPERSONNEL:  \n§ Supervise and evaluate Quality Technician and Supervisor  \nAUDITS AND INSPECTIONS:  \n§ Host audits by customers and ISO 13485 certifying body  \n§ Host FDA inspections  \nTRAINING:  \n§ In conjunction with area management, establish training requirements for staff  \n§ Issue periodic training to Quality staff  \n§ Issue periodic training to Management Staff on key aspects of QSM  \n§ Perform periodic audits of employee training records  \n§ Assess staffing needs and direct training accordingly  \nREPORTING / COMMUNICATION:  \n§ Hold weekly Quality Committee meetings with Top Management  \n§ Provide reports for trending to management review  \n§ Report on weekly activity to management team at staff meeting  \n§ Prepare and deliver Management Review meeting  \nMANAGEMENT REPRESENTATIVE:  \n§ As Management Representative, the Quality manager is responsible for ensuring quality system requirements are effectively implemented and maintained.  \n§ As Management Representative, the Quality manager is responsible for reporting on the performance of the Quality Management System to Management with Executive Responsibility.  \nJob specification of quality manager job description  \n1. Bachelor’s Degree in science or engineering and 5-10 years ’experience in Quality Assurance.  \n2. Demonstrated experience working with contract manufacturers, suppliers, or distributors.  \n3. Demonstrated exceptional written and oral communication skills.  \n4. Proficiency in Microsoft Office.  \n5. Passion and alignment with our mission, vision, values & operating principles.  \n6. Experience in 21 CFR820 and/or ISO13485 quality systems.  \n7. Desire to own decisions and take responsibility for outcomes.  \n8. Willingness to embrace personal and professional development.  \nQuality Manager Job Description 2016.doc","cbCaid8No9cW9sKP","https://ap.wps.com/l/cbCaid8No9cW9sKP","pdf",75073,"English","# Quality System\n## Personnel supervision and evaluation\n## Audits and inspections\n## Training requirements and record audits\n# Reporting and communication\n## Management Review support\n# Management representative responsibilities\n## Quality system performance reporting","[{\"question\":\"What are the primary responsibilities of the Quality Manager?\",\"answer\":\"Manage personnel in the Quality department and oversee all aspects of the Quality System, including development, implementation, communication, maintenance, and continuous improvement.\"},{\"question\":\"How does the role handle compliance and records?\",\"answer\":\"Ensure compliance with ISO 13485 requirements and relevant standards and legislation, and maintain up-to-date quality system records.\"},{\"question\":\"What audits, inspections, and training activities are included?\",\"answer\":\"Host customer and ISO 13485 certifying body audits, support FDA inspections, establish training requirements, issue periodic training, and perform periodic audits of employee training records.\"}]","Quality Manager Job Description and Responsibilities - 2016 | PDF",1789326015]