Sr Quality Assurance; QA Specialist
Listed on 2026-01-12
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Quality Assurance - QA/QC
Quality Control / Manager, QA Specialist / Manager
Sr Quality Assurance (QA) Specialist – Integrated DNA Technologies (IDT)
OverviewIDT, a Danaher operating company, is one of the world’s leading providers of life‑science instruments and reagents. The Sr QA Specialist will administer, coordinate, and maintain key components of the Quality Management System (QMS) at the Boulder, CO site, supporting product quality and regulatory compliance for a global customer base.
Responsibilities- Lead the timely completion of quality event investigations (Nonconformances, Deviations, and Customer Complaints).
- Review and release batch records, inspections, and COAs for raw materials, in‑process materials, subassemblies, and finished goods in accordance with product specifications.
- Inter‑functionally coordinate with Manufacturing, Logistics, R&D, Product Management, Supply Chain Planning, and QC teams.
- Implement, maintain, and continuously improve IDT’s QMS in accordance with ISO 13485, 21 CFR 820, and related regulatory guidance.
- Participate in internal and external audits as required.
- Bachelor’s degree in life sciences (biology, chemistry, biochemistry, or related field).
- 3+ years of QA experience in a regulated manufacturing environment, preferably in biotechnology or next‑generation sequencing.
- 3+ years of experience in medical device QA is preferred.
- Familiarity with QMS and regulatory frameworks such as ISO 9000, ISO 13485, FDA QSR, or cGMP.
- Proficiency with Microsoft Office Suite and other relevant software.
- Strong verbal, written, analytical, and persuasive communication skills.
- Experience with SAP, Master Control, and Maintenance Connection is a plus.
EEO Statement: Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities.
Salary: $85,000 – $100,000 (annual range). This role is also eligible for bonus/incentive pay.
Benefits include paid time off, medical/dental/vision insurance, 401(k) (if eligible), and more. For detail, visit Danaher Benefits Information.
the official Integrated DNA Technologies careers page and submit your application.
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