Do you want to join us in helping to fight diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
Mission:
• Lead and manage the quality function of the Shanghai reagent manufacturing site. Act as the Quality Representative for the assigned legal entity and serve as the principal authority for this critical Quality Management function.
• Implement the overarching Quality mission and strategy, ensuring execution of Quality policies and guidelines across all assigned quality areas. This role also ensures compliance with regulatory requirements, fosters a culture of quality excellence, and drives continuous improvement in quality management systems and processes.
Key tasks and responsibilities:
• Lead and manage the Quality function, including QMS, Quality Assurance, Manufacturing Quality Engineering, and Supplier Quality teams.
• Act as the Quality Management Representative (QMR) for the legal entity, ensuring quality compliance at all organizational levels, and providing strategic guidance to senior management on quality-related matters.
• Seve as the primary Quality liaison with the NMPA, ensuring effective communication with external authorities.
• Ensure effective implementation, maintenance, and continual improvement of the Quality Management System (QMS) to meet regulatory and business requirements.
• Oversee internal audits, management reviews, and external inspections; implement risk management strategies to mitigate quality-related risks in manufacturing.
• Oversee QA and QC functions to ensure consistent products and the laboratory operate under appropriate standards.
• Implement effective risk management, deviation handling, CAPA, non-conformance management and change control processes etc.
• Manage supplier qualification, audits, and continuous monitoring to ensure robust supply chain quality.
• Promote a culture of continuous improvement and operational excellence in quality.
• Partner with Manufacturing, R&D, Regulatory Affairs, and Global Quality teams to align quality strategies, goals and priorities.
• Provide guidance and training to instill quality mindset across the organization.
• Lead and develop a high-performing quality team, fostering a culture of excellence and continuous improvement.
• Other projects or tasks assigned by superior or the Company.
Desired outcomes:
• A robust, compliant, and continuously improving QMS that meets both regulatory and business needs.
• High-quality and compliant products consistently delivered to the market.
• Strong audit readiness and successful outcomes in inspections and certifications.
• Enhanced supplier reliability and quality performance.
• A culture of accountability and quality excellence embedded across the organization.
Qualifications and experience:
• At least bachelor's degree in Life Sciences, Engineering, Quality Management, or relevant.
• Minimum 15 years of progressive experience in Quality Management within medical devices, diagnostics, or pharmaceutical manufacturing.
• Solid knowledge of industry standards, and local regulatory (NMPA) requirements.
• Proven experience leading cross-functional quality teams, including QMS, QA, QC and supplier quality.
• Strong track record in regulatory inspections, audits, and certification processes.
• Excellent communication skills in both Chinese and English (written and verbal).
• Ability to influence and collaborate effectively with internal and external stakeholders.
Our global team:
We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. We aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
To all recruitment agencies:
Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.