Note: The job is a remote job and is open to candidates in USA. Mammotome, a Danaher operating company, is dedicated to innovating in the life sciences, diagnostics, and biotechnology sectors. The Technician, Quality Assurance plays a critical role in supporting the Post-Market Surveillance program, ensuring product quality and regulatory compliance through effective complaint management activities.
Responsibilities
- Perform end‑to‑end complaint intake activities, including initial assessment, documentation, routing, and accurate record maintenance in the electronic complaint management system to ensure data integrity and traceability
- Collect and verify product, usage, and event details from customers, Sales, and internal stakeholders to support thorough complaint investigations and regulatory reporting, maintaining complete, audit‑ready files
- Generate routine complaint metrics and summaries to inform trend analysis and support ongoing Quality review activities
Skills
- High School Diploma or GED
- Minimum of 1 year of experience in Quality, Manufacturing, Customer Service, or another regulated business environment
- Proven ability to work within regulated quality environments, including applying GMP and ISO requirements, using electronic documentation/quality systems and complaint management tools, and accurately documenting technical information in compliance with procedures and timelines
- Ability to travel up to 5%, domestically or internationally, as needed
- Ability to perform essential job functions in a standard office or home‑office environment, with reasonable accommodation
- Medical device, diagnostics, or other FDA‑regulated industries
- Post‑market surveillance, complaint handling, or regulatory reporting activities
Benefits
- Paid time off
- Medical/dental/vision insurance
- 401(k)
Company Overview
mammotome is a medical equipment manufacturing firm that provides breast care product design, production, and distribution services. It is a sub-organization of Danaher. It was founded in 1995, and is headquartered in Cincinnati, Ohio, USA, with a workforce of 501-1000 employees. Its website is https://www.mammotome.com.Company H1B Sponsorship
Mammotome has a track record of offering H1B sponsorships, with 4 in 2025, 3 in 2024, 4 in 2023, 3 in 2022, 4 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.