SENIOR QUALITY ASSURANCE SCIENTIST
Danaher - Miami, FL

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DIA000639

OPCO Description

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. Hospital laboratories are our core clinical diagnostic customers. Our life science customers include pharmaceutical and biotechnology companies, universities, medical schools and research institutions. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 years, our products have been making a difference in peoples lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.

Description

The Senior Quality Assurance Scientist represents QA on current business or product improvement projects. The incumbent reviews and approves all discrepancy report, process validation documentation, deviation orders, risk documentation, manufacturing batch record, test method, and specification changes associated with current business. Reviews and assures the accuracy of product labeling and compliance. Teams with other departments to facilitate failure investigations. Reviews and analyzes complex data to develop and generate quality metric reports. Responsibilities include the quality assurance oversight for the reagent manufacturing facilities.

Qualifications

BS, BA in a Life Science or related studies with 5+years in IVD industry or experienced with medical devices. Knowledge of ISO/FDA requirements experience

preferred.

Danaher Overview

Danaher is a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our portfolio of premier brands is among the most highly recognized in each of the markets we serve. Danaher's portfolio is comprised of five reporting segments: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Driven by a foundation provided by the Danaher Business System, Danaher's 48,000 associates serve customers in more than 125 countries and generated $13.2 billion of revenue in 2010.

Organization

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Diagnostics

Job Function

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Quality

Primary Location

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North America-United States-FL-Miami

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Schedule

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Full-time

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Danaher - 21 months ago - save job - block
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