Danaher Corporation Quality and Regulatory Affairs Manager - FTAP in Warsaw, Poland
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.
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.
_Main Duties_ * 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 * Manage customer complaint CAPA, POR and NCR process providing escalation as appropriate * Manage the zones Suppliers’ Quality activities * Identification and implementation of controls and reporting to cover industry specific regulatory requirements * Interface with supplier quality engineering function to drive supplier quality at plant and BU level
_Essential Qualifications/Experience_ * Degree in engineering / manufacturing or related field * Extensive experience with progressive Quality Assurance or Continuous Improvement * 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 * Must be fluent in English _Position Competencies_ * 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 judgement * Resourceful and well organized _Additional Requirements_ * Computer literacy and knowledge of quality / information systems to support HR activities * Good oral and written communication skills * 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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Eastern Europe-Poland-MZ-Warsaw
Req ID: IND000393