Crusoe6 дней назад
Senior Manager, QMS
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РЫНОК
13 634 ₽медиана по профессии
Tech Lead / Team Lead · 356 вакансий с указанной зарплатой
5 092половина предложений: 9 708–18 1041,2 млн
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Полная занятостьОфис
Обязанности
- 01QMS Framework & Governance: Own and maintain the overall Quality Management System. Establish QMS policies, standards, and governance mechanisms that bridge operational gaps and scale with manufacturing expansion.
- 02Standards & Regulatory Compliance: Maintain organizational compliance with ISO 9001, customer standards, and applicable regulatory requirements. Monitor evolving standards and translate compliance requirements into practical operational controls.
- 03Audit Program Leadership: Direct the enterprise audit program—including internal, customer, supplier, certification, and regulatory audits. Oversee audit planning, execution, finding closure, and transition the company toward a proactive quality culture.
- 04CAPA & NCR Governance: Own enterprise nonconformance (NCR) and Corrective/Preventive Action (CAPA) processes. Standardize root-cause analysis (RCA), containment, and effectiveness verification while tracking systemic trends to prevent issue recurrence.
- 05Document & Change Control: Manage the Quality Document Management System and change-control governance. Ensure current procedures, specs, and records are accessible at points of use and prevent the use of obsolete documentation.
- 06Quality Records & Systems Integration: Establish quality record data governance. Partner with IT/Business Systems to integrate QMS data across ERP, MES, and inspection tools to drive enterprise-wide quality visibility.
- 07Quality Metrics & Management Reviews: Establish cross-site quality dashboards tracking NCR/CAPA aging, audit findings, COPQ, and training compliance. Lead periodic Quality Management Reviews with executive leadership to convert quality data into strategic decisions.
- 08Training & Quality Culture: Define role-based QMS training requirements, maintain competency records, and deploy quality awareness initiatives that foster a culture of accountability and continuous improvement.
- 09Continuous Improvement & Process Maturity: Eliminate non-value-added quality steps, lead Lean Six Sigma projects, and establish closed-loop feedback between operational performance and QMS enhancements.
- 10Enterprise Quality Risk Management: Institute risk-based QMS governance. Maintain quality risk registers and ensure high-risk processes receive appropriate controls, audits, and management oversight.
- 11New Site Expansion: Lead QMS readiness activities for greenfield manufacturing sites, ensuring required procedures, forms, training, and controls are operational prior to production launch.
- 12Cross-Functional Partnership: Serve as the primary QMS subject-matter expert, partnering with Product Quality, Supplier Quality, Manufacturing Quality, Engineering, and Supply Chain to drive systemic issue resolution.
Требования
- 01Educational Foundation: Bachelor's degree in Quality, Engineering, Manufacturing, Industrial Engineering, Operations, or a related field.
- 02Professional Experience: 7+ years of experience in Quality, QMS, Quality Engineering, or Manufacturing Quality, with demonstrated success developing and scaling QMS frameworks.
- 03Quality Standards Expertise: Deep working knowledge of ISO 9001 standards, quality management principles, and regulatory compliance.
- 04Audit Management: Proven track record of planning, executing, and managing internal, customer, regulatory, and third-party certification audits.
- 05Root Cause & CAPA Mastery: Strong expertise in CAPA, NCR, 8D, 5-Why, Fishbone, and structured problem-solving methodologies.
- 06Document & Change Control Governance: Demonstrated experience managing quality document control systems, record retention, and engineering/operational change management processes.
- 07Cross-Functional Leadership: Strong ability to lead cross-functional initiatives, influence stakeholders, and drive accountability