Siemens Healthineers · 1 day ago
Quality Management System Representative
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff
$141K/yr - $194K/yr
8+ years expSiemens Healthineers is a leader in medical technology, dedicated to creating better outcomes for patients worldwide. The Quality Management System Representative will be responsible for leading management system processes, supporting organizational quality initiatives, and ensuring compliance with regulations related to medical device installations.
Health CareHealth DiagnosticsMedicalMedical Device
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
Qualification
Required
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
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
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term and short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Anton Ebert
Technology Focus Topic Lead - Digital Twinning
Recent News
2026-02-03
Medical Device Network
2026-02-02
Company data provided by crunchbase