Quality Manager (Life Science Manufacturing)

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.
Position Objective:
Planning, developing, and implementing ISO and cGMP compliance elements to enhance the Quality Management System
Project management to execute implementation plans, and drive quality objectives and goals.
Customer Audits and resolving customer complaints.
Essential Job Functions:
Manage customer complaints, nonconforming product, root cause investigation, corrective/preventive actions, audits, document control, and training daily
Assist with investigation of internal and external non-conforming product, materials, and components daily
Oversee the internal audit function to ensure ongoing compliance to the Quality Management System monthly
Perform necessary functions to verify corrective action effectiveness on manufacturing processes and support functions monthly
Develop and deliver quality training for manufacturing and support function personnel based on working knowledge of ISO, CFRs, and SOPs quarterly
Review/approve change control activities, non-conformances, customer complaint investigations daily
Manage external customer assessments from scheduling to audit close outs monthly
Responsible for measurement and analysis of Quality System trends monthly
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
Perform other duties as assigned
Minimum Qualifications:
Bachelor?s degree in Science in Engineering, Biology (or science related), or Math
5-7 years? experience in cGMP or ISO quality system manufacturing environment
2-4 years? supervisory experience (preferred)
Position Competencies:
Uses and interprets statistical data for making business decisions
Ability to explain, describe, or share information clearly; Organizes information in a framework others can understand.
Expert ability to produce effective, concise written communications about technical subjects including engineering studies, qualification protocols, and technical reports. Reviews written material and recommends revisions.
Ability to work on multiple projects, managing a broad range of tasks and prioritizing activities
Strong team-building skills; Acts to promote commitment to a team task or goal
Ability to influence peers and managers to ensure that objectives are met on time
Performs on-the-job training using tools, equipment, and materials trainees will use
Demonstrated ability to effectively manage multiple moderately complex projects simultaneously.
Must demonstrate and project integrity to employees and customers and uphold the company?s highest ethical standards
Effective interpersonal skills at any level within the organization
Lead and offer opinions and direction to colleagues
Ability to interact effectively with internal and external customers in order to accomplish goals
Other Requirements:
Knowledge in Regulatory, Compliance Systems and Standards
Knowledge of ISO, FDA, cGMP?s, and CFR requirements
Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.
Knowledge of Kepner Tregoe, SPC, and quality statistical methods and tools (preferred)
Experience in Kaizen events
Understanding and experience in the application of FMECA and DOE
Proficient computer skills in handling spreadsheets, presentations, and new systems
Ability to manage budgets
Applicable safety trainings such as: RCRA, DOT, etc.
Minimal bending, lifting, and pushing
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: Manufacturing & Operations
Primary Location: North America-North America-United States-CT-Putnam
Schedule: Full-time
Req ID: PAL001699

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