Takes ownership of moderately complex processes in the assigned area/ areas (Audits, Document Control, Training, CAPA) to ensure that QMS is efficient and meets the regulatory requirements.
Analyzes and interprets QMS performance data to identify trends, process inefficiencies, and potential areas for improvement, and presents findings to management with recommendations for action. Acts as a key liaison between the QMS team and other departments to ensure effective communication, collaboration, and alignment of QMS activities with business objectives and regulatory requirements. Provides expert guidance and support to project teams in developing quality plans, risk assessments, and process validations to ensure compliance with QMS and regulatory expectations. Leads cross-functional problem-solving sessions to address significant quality issues, utilizing structured methodologies like root cause analysis and driving the implementation of innovative solutions. Prepare for and participate in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders. Operates autonomously and contributes to development, modification, and execution of organizational policies impacting immediate operations of a business and/or region and/or function and potentially organization wide. Conducts comprehensive risk assessments and management activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing and implementing robust mitigation strategies. Champions continuous improvement initiatives within the QMS, leading efforts to enhance processes, tools, and systems, and driving a culture of quality excellence and operational efficiency throughout the organization. Mentors a group of diverse talent to develop their skills and ensure achievement of individual and team goals, and networks with key contacts outside own area of expertise and maintains strategic partnerships with external/internal stakeholders. Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
- Youre the right fit if: (4 x bullets max)
1. Experience- 12+yrs of experience in QMS
2. Skills- Deployment and proper functioning of a compliant Quality Management System (QMS), working independently under minimal supervision. The role analyzes complex QMS data, prepares detailed reports, and presents findings to leadership. The role impacts organizational policies, develops QMS processes, and collaborates cross-functionally to resolve QMS issues. The role conducts risk assessments, champions continuous improvement initiatives and mentors a diverse QMS team, fostering skill development, and maintains strategic partnerships. 3. Education- BE in any Engineering 4. Anything else- Good communication skill, it is individual contributor role.
