Head Of Quality Management And Operations

As Head of Quality at Siemens Healthineers he or she will be at the forefront of shaping our quality strategy leading a team of high-performing professionals and work closely with our executive leadership to drive quality delivery excellence - ensuring our products and services consistently exceed industry standards and regulatory compliant that influence the customer satisfaction Siemens Healthineers is built on a strong foundation of quality and integrity with a track record of earning industry certifications like ISO 13485 and accolades influencing patient centric requirements and delivery of quality productsAs Head of Quality and Visionary leader across our locations in India and Slovakia he or she will lead transformative quality initiatives work with cross-functional teams and ensure compliance in a dynamic fast-paced environmentJob OverviewAs 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 leadershipInternal Reports to the Head of TE DC GO collaborates with central function process and project owners and governs Heads of Quality Management within TE DC segments External Engages with BL partners R D and SHS QT service suppliers legal regulatory authorities third parties and supports committees Tasks and Responsibilities 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 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 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 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 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 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 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 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 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 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