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Site Quality Manager

Company: Pall
Location: Framingham
Posted on: October 11, 2020

Job Description:

About the Job Find what drives you on a team with a 70+ year history of being recognized for discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our portfolio is broad, so if your interests lie along the spectrum of Life Sciences to Industrial, you'll find a rewarding role here. Our career opportunities are as diverse as our products and they are all focused on creating better lives and a better planet. At Pall, we believe that innovation is our legacy, our privilege, and our destiny. If that resonates with you, join us!Position Summary: The Site Quality Manager leads the Pall Westborough Site Quality Management System (QMS) in accordance with the PALL Quality Systems. This is an exciting new opportunity for Pall Westborough! You will assure the management of the Quality System and Business Compliance to ensure they remain effective. You will also provide assurance of compliance with defined standards and/or specified customer requirements. This Position is necessary to create and manage the site according the ISO 9001:2015 requirements including R & D, SLS, and other Service departments. Position Competencies - Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations. - Devises strategies for compliance, and liaison with regulatory bodies. - Investigates and assists in resolution of compliance problems and questions; - Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. - Prepares regulatory submissions, negotiates the resolution of agency questions, and secures market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. - Executes appropriately on product recalls. Respond to regulatory agency inquiries. - Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements. Key Responsibilities: - Conduct internal management Review and action plans; - Maintain the Site Quality Manual7System according the actual ISO Norm 2001:2015 - Responsible for monitoring, calculation and monthly reporting of Key Quality Assurance - Performance Indicators and the Project Performance Analysis; - Optimally support the Site and Global Supplier Management Process; - Contribution/Assistance/Execution of Customer audits on site; - Responsible for training the Pall Westborough group and support the Training in quality systems requirements, policies and procedures; - Responsible for administrating, coordinating and maintaining the QMS documentation in compliance with current QMS ISO standards; - Completion of customer responses to questionnaires; Minimum Qualifications: - Bachelor's Degree Level (i.e. mechanical / process / plant engineering); - In-depth knowledge of Quality Assurance in Engineering and the Process Industry; - Excellent cross-level communication skills; - Analytical and structural thinking; - Technical flair/knowledge of system devices used in the pharmaceutical; - Customer orientated Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page-Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Pall Corporation is proud to be part of the Danaher global family of more than 20 operating companies, driving meaningful innovation in some of today's most dynamic, growing industries. 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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S & P 500 by more than 5,200% over 25 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. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. Equal Opportunity Employer Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The 'EEO is the Law' poster is available at: . Accommodations Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call or e-mail to request accommodation. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The 'EEO is the Law' poster is available here .

Keywords: Pall, Framingham , Site Quality Manager, Professions , Framingham, Massachusetts

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