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Danaher Corporation QA Specialist in Bangalore, India

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The QA Specialist for Beckman Coulter Diagnostics is responsible to execute and review of computer system validation/qualification for computer systems as per company’s procedures. This includes prepare and/or review verification and validation protocols, test cases and results traceable back to identified risks. The role, in collaboration with design and development engineering and other stakeholders, will ensure that the design intent and applicable compliance requirements are met including security controls.

Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation,processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities

This position is part of the Quality & Regulatory Affairs located in Bangalore and will be hybrid At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

IDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. Started in 2014, the center now hosts 700+ associates, for multiple Danaher operating companies focusing on Diagnostics, Life Science, and Environmental and Applied Science segments. The operating companies includes Beckman Coulter, Radiometer, Leica Biosystems, Digital Teams, Hach, Leica Microsystems, HemoCue, Videojet, SCIEX, IDBS, Laetus and Cepheid.

The IDC workforce comprises of various product engineering teams, working on development of software and hardware components of cutting-edge products for, Immunoassay, Chemistry, Hematology, Molecular diagnostics, Oncology, Neurosurgery and Water Quality. IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly hardworking software & hardware engineers and development managers. The teams are supported by local Product managers, Quality & Regulatory and Intellectual property specialists.

The inhouse teams works in close coordination with other global R&D centers at US, France, Germany, Japan, Australia, Denmark and Sweden. Located at the center of Bangalore IT HUB, IDC is housed at state of art facility.

IDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. Started in 2014, the center now hosts 700+ associates, for multiple Danaher operating companies focusing on Diagnostics, Life Science, and Environmental and Applied Science segments. The operating companies includes Beckman Coulter, Radiometer, Leica Biosystems, Digital Teams, Hach, Leica Microsystems, HemoCue, Videojet, SCIEX, IDBS, Laetus and Cepheid.

The IDC workforce comprises of various product engineering teams, working on development of software and hardware components of cutting-edge products for, Immunoassay, Chemistry, Hematology, Molecular diagnostics, Oncology, Neurosurgery and Water Quality. IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly hardworking software & hardware engineers and development managers. The teams are supported by local Product managers, Quality & Regulatory and Intellectual property specialists.

The inhouse teams works in close coordination with other global R&D centers at US, France, Germany, Japan, Australia, Denmark and Sweden. Located at the center of Bangalore IT HUB, IDC is housed at state of art facility.

You will be a part of the Quality Assurance team at IDC Bangalore and report to the Manager – Quality & Regulatory Affairs responsible for

  • Provide Quality and Compliance expertise to ensure system compliance with requirements.

  • Author and review the Validation Deliverables such as Validation Plan, Protocol and Summary reports. Provide and/or review protocols/reports / status / schedules of testing activity and results.

  • Prepare documentation as required by product development processes, Software Development Life Cycle processes in compliance with regulatory requirements, such as USFDA, ISO 13485 standards.

  • Work with other groups to follow issues to resolution.

  • Maintain and continuously develop IDC quality systems and infrastructure to ensure compliance and effectiveness

  • Liase with Quality Manager to monitor and report on the performance of the Quality Management System

  • Establish and drive successful fulfillment of Quality Management System

  • Responsible to send daily status reports and highlight risks as appropriate to the Management.

  • Liase with Management to support audits.

  • Qualification of the software for the validation labs in conjunction with the FSCs

  • Ensure compliance to organizational policies, procedures and regulatory requirements such as FDA, ISO 13485, ISO 14971

  • Knowledge on IVDR compliance

    If you thrive in a supporting role and want to work to build a world-class Quality Assurance organization—read on.

In this role, you will have the opportunity to:

  • Establish and drive successful fulfillment of Quality Management System

  • Ensure compliance to organizational policies, procedures and regulatory requirements such as FDA, ISO 13485, ISO 14971

  • Provide Quality and Compliance expertise to ensure system compliance with requirements.

  • Prepare documentation as required by product development processes, Software Development Life Cycle processes in compliance with regulatory requirements, such as USFDA, ISO 13485 standards.

  • Maintain and continuously develop IDC quality systems and infrastructure to ensure compliance and effectiveness

  • Liase with Quality Manager to monitor and report on the performance of the Quality Management System

  • Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences

  • years+ experience within the regulated environment

  • Extensive software development process experience or practical experience with product software verification and/or validation

  • Certified ISO13485, ISO14971

  • High level of autonomy and critical thinking is required. Teamwork oriented.

It would be a plus if you also possess previous experience in:

  • Certifications (ex: ISO27001 preferred)

  • Experience working with cloud services environment under regulations.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

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 80,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $29.5B in revenue last year. We are ranked #130 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 hardworking people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and bring 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: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

Accommodations

Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail applyassistance@danaher.com to request accommodation.

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.

Operating Company: Cepheid

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