Estero, FL

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Director, Quality Assurance-DIA004117

Danaher Company 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.
Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

  • Provides leadership, direction and coordinates all quality activities in accordance with the policies, goals and objectives of Beckman Coulter,
Inc. (BEC)
  • Ensures an effective quality management system that meets global regulatory

Key Responsibilities:
  • Oversees and directs the quality system to ensure business, customer and regulatory
requirements are fulfilled
  • Ensures robust product design, development, manufacture, and commercial
distribution and service through quality assurance activities
  • Ensures quality control of products through entire value stream; all steps from supplier
quality to customer delivery
  • Stays current with global regulatory intelligence
  • Partners with internal Beckman Coulter regulatory organization in pre and post-market regulatory activities including:
registrations, listings, clearances, approvals, recalls, and reporting to ensure
compliance and control of the global business
  • Partners with internal Beckman Coulter regulatory organization to ensure regulatory compliance through a functional and corporate audit program
Contributing member of the operational leadership team. Engage business decision making from a Quality leadership perspective.

Minimum Qualifications:
  • Knowledge: Familiarity with regulatory requirements for medical devices for US and
International markets. Knowledge of the regulations for medical device design,
production, distribution, pre-market registration and post-market requirements.
  • Skills: Leadership, critical thinking and decision-making, effective communication,
customer focus, business astuteness, process orientation and risk management skills
  • Bachelor's degree with 20+ years of related experience OR
  • Masters/Doctoral degree with 18+ years related experience
  • Related experience includes 6+ years managing people and creating a high performing organization
  • Degree in life sciences, engineering, sciences, or related discipline
  • Experience must include medical device, pharmaceutical or life science
  • Track record of developing effective working relationships with FDA and other
regulatory agencies and notified bodies
  • Strong business acumen with the ability to analyze and solve complex business
  • Proven ability to work cross-functionally to achieve business outcomes
Danaher Corporation Overview

Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries, including health care, environmental and communications. We are a globally diverse team of 66,000 associates united by a common culture and operating system, the Danaher Business System, which serves as our ultimate competitive advantage. In 2013, we generated $19.1 billion in revenue and our market capitalization exceeded $50 billion. We are ranked #152 on the Fortune 500 and, during the past 20 years, our stock has outperformed the S&P 500 Index by nearly 2,800 percent.
At Danaher, you'll have the opportunity to build a career in a way no other company or environment can duplicate. We're innovative, fast-paced, results-oriented, and most importantly, like to win. Why? Because it's fun! But, when it comes to the development of our leaders and associates, we're serious. Our business is growing, and we need top talented people to keep winning. The breadth and depth of our family of brands makes it possible for us to offer a variety of dynamic and challenging career opportunities across multiple global industries. Working with us, you'll have the unique experience to learn the Danaher Business System, our common operating system used to shape strategy, focus execution, align our people, and create tremendous value for customers and shareholders. At Danaher, great people do extraordinary things. Come join our winning team.
For more information please visit our website:
: Beckman Coulter

Job Function
: Quality
Primary Location
: North America-United States-CA-Chatsworth
: Full-time - 6 months ago - save job - copy to clipboard