Quality Professional/ Management System Representative

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as Quality Professional/ Management System (MS) Representative (for Regulatory Affairs (RA), Clinical Affairs (CA), Post Market Regulatory Compliance (PMRC) and Collaborations)
This is a role well suited to an ambitious professional, looking for the next step in their career. As aManagement Systems Representative, you will be responsible for:

• Represent their organization on MSLC (Management System Leadership Council). Attend quarterly meetings and pulse check calls. Leading NAM MS processes as assigned by Management.
• Support their organizations' processes; Provide input into proposed changes as needed to NAM MS (both MS and business relevant processes). Implement / drive projects, MS changes and initiatives as determined for the organization.
• Assess business, operational and/or resources changes within the organization for potential impacts on NAM MS (e.g., Site / functional / governance/BA / BL). Ensure there are training plans and training compliance in their organization.
• Support, facilitate and participate in MS audits and inspections by representing their area/ organization. Provide metrics and data for the MS dashboard, management review and other MS required reports as applicable.
• Promote MS awareness and communication, direct employees to NAM MS guidelines. Support worker consultation and participation activities throughout their area of oversight. Promote and support the business principles of Healthineers.

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

• You have a working knowledge of Management System requirements for medical device industry.
• You have management experience, or experience dealing directly with multiple levels of management.
• You have experience with FDA and HC pre and post market requirements such as submissions and AE reporting.
• You possess excellent communications and influencing skills.
• Ability to build consensus and gain action within a complex organization.
• Experience with MS, Audits and Corrective Action processes.

Required skills to have for the success of this role.

• BS in Life Sciences or Technical discipline with a minimum of 8-10 years' experience in the medical device, biotechnology, or pharmaceutical industry.
• Knowledge of FDA Quality System Regulations, Health Canada Regulations, and ISO 9001, 14001 and 45001 standards.
• Experience participating in multifunctional teams.
• Experience in presenting status updates to management.
• Displays a high level of critical thinking in bringing successful resolution to high impact, complex, and/or cross functional problems.

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