Siemens Healthineers · 5 hours ago
Post-Market Surveillance Quality Engineer
United States
Full-time
Remote
Mid, Senior Level
$103K/yr - $141K/yr
3+ years expSiemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. The Post Market Quality Engineer III is responsible for managing post-market surveillance and compliance activities for assigned products, ensuring the quality and safety of the Point of Care portfolio.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Owns and manages complex and critical complaints to ensure they are appropriately scoped, prioritized, and executed
Executes and supports technical investigations using logs, retains testing, manufacturing data, and historical field performance to drive fact-based conclusions
Ensures robust, well-documented justifications for reportable and non-reportable decisions
Fulfills global vigilance reporting requirements by drafting, reviewing, and submitting reportable incidents (e.g., MDRs, MIRs, and related submissions), including regulatory authority inquiries, and follow-ups
Manages and supports Field Action (FSCA/Recall) evaluation and execution
Tracks and reports on KPIs, trends, and post-market performance metrics
Acts as a subject-matter expert for audits and cross-functional teams
Supports and drives continuous improvement initiatives to improve the efficiency and effectiveness of post-market processes
Performs other duties as assigned
Qualification
Required
A bachelor's degree in a scientific or related technical field is required
3 to 5 years of experience and a proven track record of high performance and competency of Post-Market and Medical Device Regulations
Hands-on experience handling complaints in the Medical Device industry, specifically in Point of Care devices, and familiarity with medical device regulations
Background in quality assurance principles and practices, with knowledge of quality management systems (QMS) and relevant standards (e.g., ISO 13485)
Ability to analyze complex technical and scientific information, identify patterns, evaluate evidence, and conduct thorough investigations to support sound, risk-based decisions
Strong ability to interpret data, assess trends, and use analytical tools to support complaint investigations, surveillance activities, and reporting
Ability to communicate complex technical findings clearly and concisely in both written and verbal formats, including formal documentation and cross-functional discussions
High level of accuracy and consistency in documentation to ensure compliance and audit readiness
Ability to work effectively across R&D, Regulatory Affairs, Manufacturing, and other stakeholders to resolve issues and drive outcomes
Self-directed, accountable, and proactive in identifying improvement opportunities, adapting to regulatory changes, and strengthening post-market processes
Excellent communication skills, both written and verbal, to ensure clear and proper documentation of records
Ability to drive and deliver timely, customer-focused solutions
Proficient in Microsoft Office, specifically Excel, PowerPoint, and OneDrive
Preferred
Clinical background or field experience in a Point of Care or related setting is highly desired
Working knowledge of complaint handling, medical device reporting, CAPA, and Field Action processes within a regulated medical device environment is a plus
Data analytics skills, including PowerBI or similar professional analytical software, are desired
Ability to work on site preferred, consideration may be given to remote workers
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
2026-01-21
Company data provided by crunchbase