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Quality Assurance Regulatory Affairs Manager

Expired Job

Danaher Houston , TX 77020

Posted 5 months ago

Job Description: Job ID: IND000470

About Us

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 visit www.pall.com/green.

Description

To manage all aspects of site Quality and Regulatory Affairsactivity to support business objectives and defined CVD's. This includes theimplementation of effective quality management systems aligned to corporate andBU policies, procedures and industry specific requirements. High degree ofcustomer focus to support business growth and customer satisfaction.Leadership, development and mentoring of an effective quality team.

Implementation of effective QMS in line with Corporate, BUand local requirements

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

Manage customer complaint CAPA, POR and NCR processproviding escalation as appropriate

Manage the zones Suppliers' Quality activities

Identification and implementation of controls and reportingto cover industry specific regulatory requirements

Interface with supplier quality engineering function todrive supplier quality at plant and BU level

Job Requirements

Qualifications

Basic Qualifications:

  • Bachelors Degree

  • Minimum of 3 years of progressive quality assurance experience

  • 1+ years of experience with thorough understanding of ISO 9001, GMP knowledge

Preferred Qualifications:

  • Bachelors Degree in Engineering or Manufacturing
  • 5+ years of progressive quality assurance experience

Position Competencies

  • Proficient at Excel and Minitab

  • Able to analyze and interpret data, apply advanced concepts, practices, and procedures of the field

  • 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

Other 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

Pall 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

PALLRSR

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.


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Quality Assurance Regulatory Affairs Manager

Expired Job

Danaher