Siemens Healthineers · 14 hours ago
Senior Quality Engineer
Elkhart, IN
Full-time
Onsite
Mid, Senior Level
$89K/yr - $123K/yrSiemens Healthineers is a leader in medical technology, committed to pioneering breakthroughs in healthcare. As a Senior Quality Engineer, you will manage quality projects, conduct process reviews, support the CAPA process, and assist in regulatory preparations, all contributing to the quality culture of the engineering unit.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Managing Quality projects for the group while providing subject matter expertise of related of QMS processes
Conducting process reviews and process FMEAs
Supporting the CAPA process at site. Participating in root cause investigations
Performing routine internal audits and supplier audits as required
Assisting in preparation for FDA inspections and registrar audits
Serving as SAP QM Administrator and Quality Notification coordinator for group. Assisting with assessment and disposition of Nonconformance
Managing change control projects including related risk assessments
Reviewing and approving equipment enrollment and discrepant equipment reports
Demonstrating strong value orientation with the ability to lead teams and positively influence outcomes
Solving problems of moderate complexity
Effectively communicating with internal and external customers
Exhibiting lean leadership skills to support a continuous improvement environment
Qualification
Required
BS in Life Science – Biochemistry, Biology, or Chemistry disciplines preferred
Requires technical expertise in one or more major QMS areas: validation, nonconformance, CAPA, change management, risk assessment, test method transfer, design transfer
Requires technical expertise in the applicability of 21 CFR 820 regulations and ISO 13485:2016 standard requirements
Preferred
In Vitro Diagnostic/Immunoassay experience
SAP Quality Management
Lead Auditor
Design Transfer
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.
Founded in 1847
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
2026-01-21
Company data provided by crunchbase