Quality Assurance Specialist, IVD

5 days ago


Boulder, Colorado, United States Danaher Corporation Full time
Job Summary

At Danaher Corporation, we are seeking a highly skilled Quality Systems Specialist, IVD to join our team. As a key member of our Quality Assurance and Regulatory Affairs Department, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Maintain accurate and up-to-date records and processes for quality system functions, including complaints, NCMRs, deviations, change management, document control, audits, training, and other duties as assigned.
  • Prepare and analyze quality system performance reports for internal departmental use and management review.
  • Assist in the development and delivery of training on quality system functions.
  • Interact professionally and efficiently with manufacturing and support staff to ensure seamless intra-departmental functionality of the eQMS.
Requirements
  • Bachelor's degree in a related field or equivalent experience required.
  • Minimum 1 year of experience working in a quality assurance role required.
  • Minimum 1 year of experience working in medical devices or in vitro diagnostics required.
Preferred Qualifications
  • Strong verbal, written, analytical, and persuasive skills.
  • Ability to interact effectively with all levels of employees and management.
  • Ability to perform a variety of duties with minimal supervision.
What We Offer

We offer a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. Additionally, this role is eligible for bonus/incentive pay.

We are an equal opportunity employer and welcome applications from diverse candidates. If you require accommodation during the application or interview process, please contact us at applyassistance@danaher.com.



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