Quality Program Manager [Remote/Tarrytown,Ny]

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.

At Siemens Healthineers, 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 LS-QT CS Program Manager.

Position Summary

The QT-LS CS Program Manager will work closely with DX-LS and POC QT, DX CS, and SHS CS to construct a global strategic vision for execution of a revised Quality System strategy for Siemens Healthcare Diagnostics, Inc.

The program Manager will construct a financial analysis of both current and potential future Quality Systems structures that allow for improvements in efficiency, effectiveness, and compliance. This effort will include establishing new procedures, refining existing procedures, reviewing and recommending electronic tools. Overall, this is a partnering role to a broad group of constituents across Siemens Healthineers. The recommendations must fit withing the requirements of ISO 13485, MDSAP, and the regulations of the countries within which Diagnostics operates. The recommendations must also be financially scalable in association with anticipated growth.

Requires a bachelor's degree in environment, health, safety or related engineering/scientific areas and/or 10 years of experience in Medical Devices, In-Vitro Devices, or similar industry and involving servicing of significant capital equipment. Must be able to demonstrate expertise and experience in a variety of the field's concepts, practices, and procedures. Relies on extensive analysis and product operational experience and judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected. Will work closely with LD QT Project Management Office as needed.

Our global team: We are a team of more than 68,000 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.

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. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a LS-QT CS Program Manager you will be responsible for:

Essential Job Functions

Responsibilities include but are not limited to the following:

• Manage and analyze complex data from multiple sources

• Understand, coordinate and present financial data demonstrating pros/cons of multiple concepts

• Have functional knowledge of GMP, ISO 13485, MDSAP impact on Field Service processes and operations

• Have a customer and patient focused orientation when defining new systems and processes

• Coordinate cross-functional efforts between numerous stake holders and IT

• Updates LS-QT and DX CS Management Team on a regular basis to ensure the business stays ahead of any new standards and/or legal requirements

• Responsible for the documentation and reporting requirements of all special project activities

• Issues monthly regulatory updates to the LS-QT Management Team

Critical Competencies

• Attention to detail and quality in all initiatives

• Strategic project management skills - with a strong emphasis on regulatory projects and budget experience

• Experience working and collaborating with inside and outside organizations

• Creativity in organizational approaches to solutions/issues

• Ability to adapt to new approaches in the Field Service function

• The ability and experience to relate well and establish/maintain credibility with senior leadership.

• Demonstrated excellent performance in previous role and project work and documented high potential for development and growth in this new position

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineer

Required skills to have for the success of this role

• Ideal candidate would have 5 years or more of managerial experience
• Previous experience working with the European Union Directives a plus
• Previous experience working within regulatory associations such as AdvaMed and EUMedTech a plus
• Previous experience with GMP, ISO 13485 and MDSAP inspections and audits
• Bachelors Degree with 8 – 12 years of experience in Quality Systems or related field

The pay range for this position is 140K-190K annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is (15%) of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html

This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

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.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://jobs.siemens-healthineers.com/careers

If you wish to find out more about the specific division before applying, please visit: https://usa.healthcare.siemens.com/about.

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As an equal-opportunity employer we are happy to consider applications from individuals with disabilities