Head of Quality for Point of Care Diagnostics
Do you want to join us in helping to fight the world’s most threatening 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. Sound interesting? Then come and join our global team as Head of Quality for Point of Care Diagnostics.
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. As a leader in the industry, 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.
The Head of Quality leads the overall quality management, compliance and regulatory affairs functions for the Point of Care Diagnostics Business Line within Siemens Healthineers. Major responsibilities include the establishment of the company’s Quality Management Systems, development, and execution of regulatory strategies to support the timely approval of regulatory submissions in support of the company’s corporate objectives. Designated Management Representative for the POC Business Line who ensures that the Quality Management System is established, maintained, and periodically assessed for its performance. The position reports to the President and Head of Point of Care Diagnostics (POC) and is a member of the POC leadership team.
- Leads the POC Global Quality Management and Regulatory Affairs organization setting strategic direction for the overall Quality System.
- As appointed Management Representative:
- Ensures Quality Management System is established, implemented, and maintained
- Reports to top management on Quality System performance
- Ensures promotion of awareness of regulatory and customer requirements throughout the organization
- Hosts regulatory body audits.
- Oversees implementation of quality and safety procedures and protocols that ensure compliance and product reliability.
- Compiles and communicates information related to quality management system effectiveness, ensuring all work is in accordance with quality system procedures.
- Reviews product development, quality assurance, manufacturing, quality system, marketing, and clinical research study reports and other regulatory documents.
- Leads the overall regulatory submission and approval effort with strategic vision and sound strategies.
- Implements company regulatory strategies for the development of new products and product enhancements to achieve marketable products in an efficient and effective manner.
- Maintains outstanding relationships with all key internal customers and regulatory agencies. Interacts with the FDA (and international regulatory agencies) on a proactive, independent, and frequent basis.
- Evaluates external business development opportunities from a quality and regulatory perspective and provides feedback as a member of the POC Leadership Team.
- Manages Quality and Regulatory functional budgets.
- Ensures appropriate communication processes are established within and across functional groups.
- Aligns and coordinates closely with the Clinical and Medical Affairs team in the Diagnostics (DX) Business Area.
Key Skills & Experience
- Successful track record in leading global Quality and Regulatory organizations in the In Vitro Diagnostics or Medical Device business.
- Excellent understanding of domain specific standards, regulations and norms, especially FDA QSReg, ISO13485, IVDR, NMPA.
- Experience in leading a Business Line Quality and Regulatory organization - including pre-market activities, post market surveillance, registration activities (Regulatory Affairs) and Quality Audits (e.g. FDA, TÜV).
- Experience with global regulatory agencies and worldwide regulations across the whole product lifecycle ensuring fast market access, supporting and protecting the business, ensuring customer satisfaction and patient safety.
- Knows how to operate efficiently in a matrixed environment: is known to be a strong collaborator partnering across functions within the business and beyond, leverages peer and expert networks to define the quality strategy and execute on it.
- Is a thought leader in quality management: benchmarks best practices across the business both internally and externally, deploys global quality company standards and processes while adapting those to the business specific needs.
- Thinks enterprise before function and uses expertise at the Leadership table to drive portfolio value.
- Has a track record in operational excellence, translating complex quality strategies into clear and realistic execution plans. Knows how to deliver under time pressure with optimum use of resources.
- Thinks long-term, simplifies complexity, and drives strategies that are realistic for the organization.
- Ensures Regulatory Compliance and right to operate while balancing the need of the business impact.
- Ability to interpret external regulations and standards with a solution oriented can-do mindset.
- Shows ownership and accountability, takes smart risk-based decisions commensurate with business impact.
- Champions a culture of continuous improvement across all areas of responsibility.
- Extensive experience managing global and highly complex teams in both a direct and matrixed environment
- Builds, motivates, and develops diverse global high-performing teams.
- Leads from the front, delegating and holding self and others accountable to stretch goals.
- Drives change and transformation in own team and organization.
- Is resilient, stays humble and role-models learning.
Required Education & Work Experience
- Bachelor’s degree in Engineering or Life Sciences (MS or PhD strongly preferred) and 15+ years of medical device /IVD industry experience, including 5+ years of technical management responsibilities.
- Previous experience in the development and execution of regulatory strategies leading to medical device market clearance/approval and responsibility over quality management is necessary with a balanced combination of each preferred.
- Extensive experience managing global and highly complex teams in both a direct and matrixed environment.
- Working knowledge of FDA, ISO and Medical Device Directives of European Council required.
- Working knowledge of NMPA regulations desired.
- Regulatory Affairs Certification (RAC) desired.
- Excellent communications skills (both written and verbal) required.
- Excellent presentation skills required.
- Ability to work independently or in team setting required.
- Ability to travel extensively.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
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If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
“Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Full / Part time: Full-time
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