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Danaher Corporation Senior Analyst Quality Assurance in Bangalore, India

Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence.

Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Position Summary:

This position will be primarily responsible for the compliance of Beckman Coulter Bangalore Development Centre Design Control processes to 21 CFR 820, EU Regulation 2017/746, ISO 13485, ISO 9001, MDSAP, Beckman Coulter and Danaher corporate Quality system requirements and to support new product development, risk management and product life cycle management from a Quality and Regulatory Standpoint for IVD and research products.

Essential Duties and Responsibilities:

  • Ensure management of all design control activities to meet company’s business needs, developing company best practices, standards, and continuous improvement, and ensure compliance to regulatory requirements and standards

  • Ensures FDA QSR (GMP), EU Regulation 2017/746 (IVDR), ISO 13485, ISO 9001, MDSAP and/or other national or international standards are continuously met with respect to design control and risk management activities

  • Develop and implement comprehensive Quality plans for new product development and design changes

  • Ensures Design History Files are adequately prepared and maintained

  • Supports external audits and inspections as SME for design control processes.

  • Supports conduct of Quality System Management Review meetings by ensuring comprehensive analysis of Quality System data and identifying root cause and improvements

Education and/or Experience:

  • Master’s degree in science, medical or technical field and 9+ years’ experience with increasing responsibility in Quality and Regulatory Affairs

  • Prior experience in Design Quality Assurance and Risk Management is required.

  • Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable

  • Demonstrable understanding of at least some of the domestic and international quality systems and other standards such as Indian Medical Devices Rule, 2017, FDA QSR, IVDR, MDSAP, SFDA, JPAL, ISO 13485, ISO 14971 or other applicable standards and regulations

Preferred Requirements:

  • Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR), EU regulation 2017/746 (IVDR) and ISO 13485

  • Creation of Technical documentation for submission to FDA/Notified bodies

  • Technical understanding of assay development. Knowledge of flow cytometry is highly desirable.

  • Knowledge/experience of validation activities involved in design transfer of new products.

  • Able to interpret regulatory requirements and establish practical solutions within a dynamic business environment.

  • Cross functional experience with products and manufacturing processes to influence change at appropriate levels within the organization

OTHER SKILLS and ABILITIES

  • Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators

  • Ability to drive results, foster teamwork, handle pressure, and provide feedback

  • Must be able to demonstrate skills in root cause investigation and problem solving

  • Must have critical thinking skills and good judgment working in an independent environment

  • Organized and detail-oriented

  • High level of initiative, self-motivation and energy.

  • Reliable and responsive.

  • Customer focused

  • High level of integrity

  • Goal oriented, interpersonal, self-motivated and team player

Preferred Requirements

  • Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485

  • Experience in leading continuous improvement efforts, in both quality systems and products.

  • Track record for successfully driving multi-faceted cross functional projects, including CAPA projects.

  • Cross functional experience with products and manufacturing processes to influence change at all levels within the organization

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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