Danaher Corporation · 3 months ago
Sr Quality Assurance (QA) Specialist
Boulder, Colorado, United States
Full-time
Onsite
Mid, Senior Level
$85K/yr - $100K/yr
3+ years expIntegrated DNA Technologies (IDT), a part of Danaher Corporation, is focused on innovation in life sciences and biotechnology. The Sr Quality Assurance (QA) Specialist will oversee the Quality Management System at the Boulder, CO site, ensuring compliance and facilitating quality event investigations.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Ensure the timely completion and investigation into Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints)
Complete timely review and release of batch records, inspections, and COA creation for various raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications
Interact professionally and efficiently cross functionally with Manufacturing and various support teams; Logistics, R&D, Product Management, Supply Chain Planning, and QC
Implement, maintain, and improve IDT’s Quality Management System in accordance with ISO 13485, 21 CFR 820 and regulatory guidance documents. Works with the IDT Global QS team
Participate in internal and external audits, as needed
Qualification
Required
Bachelor's degree in life sciences preferably in one of the following biology, chemistry, biochemistry or related field
3+ years of Quality Assurance experience in a manufacturing industry, biotechnology and next-generation sequencing preferred
3+ years of experience working in medical devices preferred
Experience with quality management systems and regulatory standards such as ISO:9000, ISO:13485. FDA QSR, or cGMP is preferred. Candidates should be able to demonstrate familiarity with one or more of these frameworks through prior experience in a regulated environment
Proficiency with computers and a variety of software i.e. Microsoft Office Suite, etc
Preferred
Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management
Ability to accept responsibility for the direction, control or planning of a project
SAP, MasterControl, and Maintenance Connection
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
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
Mobihealthnews
2026-01-16
2026-01-14
Company data provided by crunchbase