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Danaher Corporation.

Site Quality, Regulatory Affairs and CAPA Manager

Danaher Corporation. - Grand Island, NE

Site Quality, Regulatory Affairs and CAPA Manager

in

Grand Island

Nebraska

Danaher Company Description

Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.

Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.

Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.

Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.

To learn more about Pall, please visitwww.pall.com/green.

Description

Position Summary:

To manage all aspects of site Quality and Regulatory Affairs activity to support business objectives and defined CVD’s. This includes the implementation of effective quality management systems aligned to corporate and BU policies, procedures and industry specific requirements. High degree of customer focus to support business growth and customer satisfaction. Leadership, development and mentoring of an effective quality team. Maintain focus on plant customer complaint, CAPA and NCR status.

Implementation of effective QMS in line with Corporate, BU and local requirements

Continuous improvement of Core Value Drivers in support of quality and business growth

Undertake customer complaint CAPA and NCR process providing escalation as appropriate

Identification and implementation of controls and reporting to cover industry specific regulatory requirements

Lead, mentor and rigorously develop talent within the quality function

Interface with supplier quality engineering function to drive supplier quality at plant and BU level * Degree in engineering / manufacturing or related field * Minimum of five (5) years of progressive quality assurance experience * Sound knowledge of ASME and PED * Must be proficient at Excel / Minitab and able to analyze and interpret data * Applies advanced concepts, practices, and procedures of the field * Thorough understanding of ISO 9001,GMP knowledge an advantage * Considerable demonstrated skills in listening and communicating effectively with diverse individuals, groups; facilitating trust and understanding * Coaching, counseling and feedback skills * Superior interpersonal abilities * Good reasoning abilities. Sound judgment * Resourceful and well organized

Qualification

Strong knowledge of applicable federal and local product / application laws and regulations

Breadth and depth of quality generalist knowledge

Ability to function effectively in a global / matrix organization

Well-developed administrative and management skills

Understanding of the manufacturing business, ISO and cGMP knowledge is preferred

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Organization:

Pall

Job Function:

Management

Primary Location:

North America-North America-United States-NE-Grand Island

Schedule:

Full-time

Req ID:

PAL001641

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Danaher Corporation.

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Site Quality, Regulatory Affairs and CAPA Manager Danaher Corporation. - Grand Island, NE, United States

   

Location: Grand Island, NE

Company Profile:
Microscopes that let researchers see life at 100 nanometers in three dimensions. Dental diagnostics that spot decay as it forms, enabling painless, noninvasive treatments. Disinfection technologies that help ensure safe drinking water at the rate of billions of gallons of water a day. Transaction systems that bring new levels of speed and security to consumers. Network analyzers that link seamlessly with sophisticated software to maximize uptime. Danaher products span some of the most demanding applications in the world, creating new possibilities not only for those who use them, but for millions more who never give them a moment’s thought. In every case, they’re delivering benefits that matter to markets that are eager for innovation. And we are doing it through a customer-centric approach that unites our businesses and has made them global leaders.