As Head of Quality and Quality Management Representative, the mission is to develop, maintain, and optimize a Quality Management System aligned with business needs and certifications. He or she advises TE DC management on quality and regulatory requirements, manages quality personnel, and drive continuous improvement for world-class quality. As a key management team member, the Head of Quality ensures regulatory and customer requirement awareness, oversees quality activities across TE DC. In addition, He or she handles EHS Management System responsibilities for TE DC IND site(s). The Quality Head holds global responsibility for the TE DC QMS, ensuring its effectiveness and efficiency. They define policies and operational targets for customer satisfaction, regulatory compliance, and quality standards as per QAA, regularly report on progress, and conduct management reviews with TE DC leadership.
Tasks and Responsibilities
Managements Systems – QMS and EHS MS: Develop, implement, maintain, and enhance a consistent QMS and EHS MS for TE DC, ensuring certifications meet internal and external quality/regulatory requirements and align with the Siemens Healthineers Process Framework. Ensure Siemens Healthineers standards and QM responsibilities are met, coordinate third-party activities, ensure corporate compliance for product safety, and align improvement programs, resources, and synergies with EHS.
Planning:Ensure business-driven Quality/EHS planning in TE DC, including an integrated quality plan if needed. Focus on identifying critical business issues, prioritizing improvement projects, planning budgets and resources, selecting KPIs, setting benchmarked targets, and coordinating quality-related goals for management, individuals, and teams.
Performance Monitoring and reporting: Monitor compliance with quality/regulatory and EHS requirements and performance through a quality information system with KPIs. Report quality performance to TE DC Management and SHS QM for evaluation and improvement. Conduct management reviews and communicate quality and EHS topics and metrics widely to all stakeholders.
Process and Product Quality: Ensure the use of quality tools in processes and projects, such as quality gates, and exercise authority to halt development, production, shipping, or acceptance if necessary. Include outcomes in the TE DC quality report.
Environment Protection, Health Management and Safety: In a capacity as an EHS Officer ensure environmental protection, health management, occupational safety, radiation protection, fire protection and hazardous materials/dangerous goods transportation services at the TE DC IND sites, in alignment with SHS Health Management and 14001 and 45001 standards.
Continuous Improvements: Plan, initiate, and coordinate continuous improvement activities with TE DC. Develop concepts with defined roles, integration into processes and projects, tools, management focus, and adequate resources. Promote best practice sharing and include results in the TE DC quality report. Ensure BLs partners feedback is analyzed and managed through defined action plan and improvements
Competence development and Training: Coordinate with HR training to establish Quality and HES competences. Develop and deliver training on quality, EHS, processes, regulations, roles, and tools. Identify competency gaps, assess program effectiveness, and ensure qualified staffing for TE DC QM roles.
Audits and assessments: Plan and conduct audits (including certification audits) and assessments. Recommend improvements, ensure follow-up, and incorporate results into the TE DC quality/EHS report. Ensure QMS and EHS MS compliance with ISO standards ISO 9001, ISO 13485, ISO 14001, and ISO 45001 are met.
Communication: Implement a communication strategy to promote TE DC-wide understanding of the quality framework and culture. Ensure controlled external communication with customers, suppliers (in coordination with Procurement), and regulatory authorities.
Regulatory: Ensure TE DC regulatory requirements (Indian MDR, Indian CPCB, EU MDR/IVDR and US FDA) are defined, processes are developed to meet them, resources are aligned, and interfaces are created as needed to ensure compliance.
Essential Experiences and skills
15+ years in professional experience in software and system development environment. Working experience in medical devices development is a plus and preferred.
Deep understanding of regulatory and quality standards (e.g., ISO 9001, ISO 13485, Indian MDR, EU MDR/IVDR and FDA regulations), strong audit experience, risk management, reporting, continuous improvement processes. Experience in Project Management, Quality Management, process improvement and regulatory compliance
Strong leadership, strategic thinking, deep regulatory knowledge, excellent communication, and a focus on risk management, customer satisfaction, and continuous improvement.
Working experience in a cross-country/cross-cultural organization a plus
Engineering degree from a recognized University with Quality and software Engineering exposure and experience
