Quality Management System Representative

Siemens Healthineers

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Quality Professional/ Management System (MS) Representative for Customer Supply Chain (CSC), Project Management & Installations, CBS Order Entry Logistics. Elaborates and analyzes implements quality concepts, methods, tools and procedures as part of effective an agile/lean-oriented Quality Management System, in a specific quality area, or in an assigned organizational unit as identified above. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Management System 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 (Management System) processes as assigned by Management. Support their organization’s 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. Specifically, you will support and interact with modality directors, zone leaders and project managers on product, documentation, field issues, training and regulatory requirements related to installation of products. Interact and support the team with oversight of our mechanical installation vendors (MIV) including quality and performance issues: KPIs and documentation/ record issues. Support order management / discrepancies teams and Canada project management. Manage the suppliers that support installation areas. 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. Manage KPI reporting for areas that you support as described above through various reporting channels. 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 imaging and diagnostic device installations and logistics operations. Experience with project management and working with country, state, provincial and local regulatory requirements You possess excellent communications and influencing skills. Ability to build consensus and gain action within a complex organization. Experience with MS, Audits, Corrective Action, Supplier Management 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. Experience with management and oversite of suppliers. Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here.

Requirements

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 imaging and diagnostic device installations and logistics operations.
Experience with project management and working with country, state, provincial and local regulatory requirements
You possess excellent communications and influencing skills.
Ability to build consensus and gain action within a complex organization.
Experience with MS, Audits, Corrective Action, Supplier Management processes.
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.
Experience with management and oversite of suppliers.

Responsibilities

Represent their organization on MSLC= Management System Leadership Council.
Attend quarterly meetings and pulse check calls.
Leading NAM MS (Management System) processes as assigned by Management.
Support their organization’s 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.
Specifically, you will support and interact with modality directors, zone leaders and project managers on product, documentation, field issues, training and regulatory requirements related to installation of products.
Interact and support the team with oversight of our mechanical installation vendors (MIV) including quality and performance issues: KPIs and documentation/ record issues.
Support order management / discrepancies teams and Canada project management.
Manage the suppliers that support installation areas.
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.
Manage KPI reporting for areas that you support as described above through various reporting channels.
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.