STAFF QUALITY ASSURANCE SCIENTIST
Danaher - Chaska, MN

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DIA000294

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 people’s lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.

Description

  • Provide scientific review of quality programs, which provide the basis for
sound business and technical decisions

  • Consults with other departments on scientific processes, product and process
improvement, and new product development

  • Provides key input to technical decisions by systems analysis of interacting
affects of designs and processes

  • Prepares and issues assigned quality reports
  • Coordinates compliant management activities and recommend appropriate field
actions to product regulatory committees

  • Determines and/or recommends direction taken in technical product or
manufacturing issues

  • Recommends design, reviews and/or approves experiments
  • Reviews and/or comments on technical content of intra and interdepartmental
reports

  • Provides design review and risk assessment expertise. Proposes new methods or
techniques for validation programs.

  • Consults on OEM activities and internal/external audits. Provides input to
specifications and product definitions.

  • Provides technical support on manufacturing and design issues. Advises on
technical aspects of compliance regulations.

  • Exercises judgment within broadly defined practices and policies in selecting
methods, techniques and evaluation criterion for obtaining results.

  • Formulates/monitors project plans. May assign work to others (intra and
interdepartmental) May be the key contact for outside application/technology

providers.

  • Leads process improvements, training, and guidance of technical staff.
  • Adheres to policies and procedures. Exercises independent judgment in quality
assurance related activities.

  • Develops advance concepts, tests, and designs for complex issues. Recommends
or terminates external resources (contractors). Initiates or recommends stop

shipment actions.

  • Ability to influence cross functionally and within a larger manufacturing
operation.

Qualifications

  • BS Degree in engineering, ID, or Quality, or related field
  • CQE preferred
  • 5-7 years experience in quality management (mfg) with experience in medical
devices, pharma, or related field under FDA Regulatory supervision

  • Staff management experience
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-MN-Chaska

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Schedule

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Full-time

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About this company
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