Beckman Coulter Life Sciences · 10 hours ago
Staff Quality Assurance Engineer
Loveland, CO
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expBeckman Coulter Life Sciences is a leading company in life sciences, diagnostics, and biotechnology. The Staff Quality Assurance Engineer is responsible for facilitating the application of quality system and design control processes across product development, ensuring compliance with industry standards.
BiotechnologyLife ScienceManufacturing
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
Ability to identify, develop and execute quality system, product and process improvements. Driving change cross functionally across multi-site operations
Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired
Experience with product software development lifecycle management
Benefits
Health care program
Paid time off
Company
Beckman Coulter Life Sciences
Beckman Coulter Life Sciences develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests.
1001-5000 employees
H1B Sponsorship
Beckman Coulter Life Sciences 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 (34)
2024 (27)
2023 (27)
2022 (38)
2021 (26)
2020 (32)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
National Cancer Institute
2025-01-22Grant
Leadership Team
Alex O.
Sr. Director - IT Business Partner for Beckman Coulter Life Sciences
Giuliana Diaz
Sr. Human Resources Business Partner
Recent News
synbiobeta.com
2025-11-21
2025-11-19
Research and Markets
2025-11-18
Company data provided by crunchbase