STAFF QUALITY ASSURANCE ENGINEER
Beckman Coulter - Miami, FL

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BEC000401

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

Provide scientific review of quality programs, which provide the basis for sound business and technical decisions. Consult with other departments on scientific processes, product and process improvement, and new product development. Provide key input to technical decisions by systems analysis of interacting affects of designs and processes. Prepare and issue assigned quality reports. Coordinate compliant management activities and recommend appropriate field actions to product regulatory committees. Determine and/or recommend direction taken in technical product or manufacturing issues. Recommend design, review and/or approve experiments. Review and/or comment on technical content of intra and interdepartmental reports. Provide design review and risk assessment expertise. Propose new methods or techniques for validation programs. Consult on OEM activities and internal/external audits. Provide input to specifications and product definitions. Give technical support on manufacturing and design issues. Advise on technical aspects of compliance regulations.

Qualifications

Experienced Quality professional with a baccalaureate college degree in Engineering (Biomedical preferred) and at least 10 years of relevant experience in the regulated medical device/diagnostics industry. Graduate degree and in vitro diagnostics experience preferred.

Proven expertise with interpreting, applying, and leading others in compliance with the following; USFDA Quality System Regulations for Medical Devices; EU IVD/MD Directives, ISO 13485 Quality Standard, and ISO 14971 Risk Management Standard.

Proven expertise in medical device design controls including; experimental design, design validation and risk management.

Proven experience in project management/leadership of teams and teambuilding.

Knowledge of the pre and post-market Quality aspects of the medical device product lifecycle.

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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Beckman Coulter

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 - 2 years ago - save job
About this company
137 reviews
Beckman Coulter, Inc., the largest operating company of the Danaher family, is a manufacturer and marketer of biomedical testing instrument...