Zeiss—QMS Lead

Job description

Description: ZEISS in India ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics. ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace. Further information at ZEISS India. The QMS Manager is responsible for establishing, implementing, maintaining and continually improving the Quality Management System across the organization. The role will ensure that the company's QMS is compliant with applicable standards, customer requirements and internal procedures, and that all processes are effectively documented, controlled, monitored and improved. The position will focus specifically on QMS governance, documentation, audits, CAPA, risk management, change control, management review and continual improvement. Key Responsibilities A. QMS Development & Maintenance - Develop, implement and maintain the company's Quality Management System. - Establish and maintain the Quality Manual, Quality Policy, procedures, SOPs, work instructions and QMS formats. - Ensure QMS processes are implemented consistently across all applicable departments. - Periodically review the QMS for effectiveness and suitability. - Identify gaps in the existing system and implement improvements. - Ensure the QMS remains aligned with business and customer requirements. B. Document Control - Establish and maintain an effective document-control system. - Control creation, review, approval, revision and distribution of QMS documents. - Ensure only current and approved documents are available at points of use. - Control obsolete documents and maintain revision history. - Maintain the master list of controlled documents. - Ensure proper control and retention of quality records. - Define document and record retention requirements. - Monitor compliance with document-control procedures. C. Internal Audit - Prepare and maintain the annual internal audit program. - Develop audit schedules based on process importance, risk and previous audit results. - Conduct and/or coordinate internal QMS audits. - Ensure auditors are appropriately trained and independent where required. - Prepare audit reports and communicate audit findings. - Monitor corrective actions arising from internal audits. - Verify effectiveness of actions before closure. - Maintain complete internal-audit records. D. External & Certification Audits - Act as the primary QMS coordinator for certification and surveillance audits. - Coordinate customer and third-party QMS audits. - Prepare the organization for external audits. - Ensure required QMS documents and records are readily available. - Coordinate responses to audit findings. - Track corrective-action commitments and closure. - Maintain audit history and certification records. - Ensure timely preparation for upcoming audits. E. CAPA Management - Establish and maintain the organization's CAPA system. - Review NCRs, audit findings, customer complaints and recurring issues requiring CAPA. - Ensure appropriate root-cause analysis is performed. - Monitor corrective and preventive action plans. - Track CAPA status and overdue actions. - Verify objective evidence of implementation. - Evaluate CAPA effectiveness before closure. - Identify recurring issues and recommend systemic improvements. F. Non-Conformity Management - Maintain the QMS process for handling non-conformities. - Ensure non-conformities are properly documented and investigated. - Monitor corrective-action requirements. - Maintain records of non-conformities and their disposition. - Analyze non-conformity trends. - Escalate significant or recurring QMS issues to management. G. Risk Management - Establish and maintain the QMS risk-management framework. - Coordinate identification and assessment of process risks. - Maintain risk registers where applicable. - Ensure risk assessments are reviewed following significant changes or incidents. - Monitor risk-control actions. - Integrate risk-based thinking into QMS processes. - Ensure high-risk processes receive appropriate management attention. H. Change Management - Establish and maintain the QMS change-control process. - Ensure changes to processes, documents, systems and organizational requirements are formally evaluated. - Assess the quality and QMS impact of proposed changes. - Ensure appropriate approvals are obtained before implementation. - Maintain change-control records. - Verify effectiveness after implementation where required. I. Management Review - Plan and coordinate Management Review Meetings. - Prepare the QMS Management Review agenda and inputs. - Consolidate required performance information and QMS data. - Record management decisions, actions and responsibilities. - Track Management Review action items through to closure. - Maintain Management Review records. - Monitor effectiveness of actions arising from Management Review. J. QMS Performance Monitoring Establish and monitor QMS-related KPIs, including: - Internal audit completion - Audit finding closure - CAPA on-time closure - CAPA effectiveness - Document review compliance - Training compliance related to QMS - Customer-audit findings - Certification-audit findings - Recurring non-conformities - Management Review action closure - QMS improvement actions Prepare periodic QMS performance reports for management. K. Training & QMS Awareness - Develop QMS awareness and training programs. - Ensure employees understand applicable QMS procedures and responsibilities. - Coordinate training on document control, CAPA, internal auditing, risk management and other QMS requirements. - Maintain QMS training records. - Monitor effectiveness of QMS-related training. L. Continual Improvement - Identify opportunities to improve the effectiveness of the QMS. - Drive QMS improvement projects. - Analyze audit, CAPA, non-conformity and other QMS data to identify systemic issues. - Promote preventive and risk-based approaches. - Review the effectiveness of implemented QMS improvements. Your ZEISS Recruiting Team: Jayashree V