Danaher Corporation · 5 months ago
Staff Quality Assurance Engineer
Indianapolis, Indiana, United States
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expDanaher Corporation is a leading company in life sciences and biotechnology, committed to innovation and impactful solutions. The Staff Quality Assurance Engineer will facilitate quality system applications and design control processes across Beckman Coulter Life Science products, ensuring compliance and quality throughout the product lifecycle.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Representing quality assurance on development teams, quality systems and product improvement projects for Beckman Coulter Life Science
Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product lifecycle
Partnering cross functionally to ensure product and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls
Assuring compliant process and product documentation, inclusive of Design History, Product, Process and Service documentation in support of product realization and commercialization within the Beckman Coulter quality system
Awareness of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance
Qualification
Required
Degree in engineering or other science or related field; or equivalent experience required
BS+7 or MS+4 years' experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries
Preferred
Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired
Experience with product software development lifecycle management
Benefits
A broad array of comprehensive, competitive benefit programs
Health care program
Paid time off
Company
Danaher Corporation
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
10001+ employees
H1B Sponsorship
Danaher Corporation 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 (7)
2024 (4)
2023 (3)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown1979-01-05IPO
Leadership Team
Rainer Blair
President & CEO
Thomas Joyce
President & CEO
Recent News
mass-spec-capital.com
2026-01-09
2026-01-08
2026-01-05
Company data provided by crunchbase