Senior Staff Quality Assurance Scientist
Danaher - Danvers, MA

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DIA000358

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



Assures compliant and complete product documentation, inclusive of DHFs and DMRs that support domestic and international product submissions, as well as successful and compliant product realization.



Assures newly developed products are successfully transferred into the manufacturing environment.



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 effects of designs and processes



Provides strategies in the areas of development, risk, test and verification.



Provides design review and risk assessment expertise; recommends design, reviews and/or approves experiments



Proposes new methods or techniques for validation programs.



Develops advance concepts, tests, and designs for complex issues. Recommends stop shipment actions.



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



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



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



Prepares and issues assigned quality reports



Reviews and/or comments on technical content of intra and interdepartmental reports



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



Leads process improvements, training, and guidance of technical staff.

Contributes to the Quality System via process development, process improvement and training.



Adheres to policies and procedures. Exercises independent judgment in quality assurance related activities.



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



Other activities as assigned.

Qualifications

BS Degree in engineering, Life Science, or related field

MS Degree or higher preferred

CQE preferred

5-7 years experience in product development, manufacturing and / or quality in medical device, pharma, or related field under FDA Regulatory supervision

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-MA-Danvers

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Schedule

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Full-time

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About this company
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