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Danaher Corporation QA Validation Associate I in Bangalore, India

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@Cepheid News).

This position is for Cepheid team located at Danaher India Development Center (IDC), Bangalore

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 500+ 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, Danaher Digital, Hach, Leica Microsystems, HemoCue, Videojet 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 skilled 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, measuring 120 K Sqft.

Job Description:

Cepheid is looking for a Software Quality Validation Engineer position that supports quality systems activities related to software validation, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects or activities using existing procedures and under direct supervision.

Essential Job Responsibilities:

  • Perform duties as an individual contributor and/or team member with 100% hands-on work

  • Participate in the submission, execution and review of test protocols in accordance with SOPs

  • Record, report, and verify software defects to accurately depict the software requirements

  • Participate in test protocol updates and test design reviews

  • Work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects

  • Participate in Validation to ensure the software meets user needs requirements of user workflows for a regulated environment

  • Provide test data to drafts of validation report

  • Create change orders in document control system

  • Update traceability matrices and quality metrics

  • Participate in daily management using DBS tools

What We Are Looking For:

  • BA/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field.

  • 2+ years of software testing experience in a regulated environment.

  • Understanding of FDA and ISO regulations, e.g., design controls, risk management, and software validation.

  • Experience with: Windows environments, Web application testing, and working knowledge of SQL, including the ability to run queries, and interpret results.

  • Self-motivated, willing to learn new concepts, technologies and products quickly.

  • Excellent interpersonal, writing and communication skills, and troubleshooting skills.

  • Passionate about testing, product quality, and customer satisfaction.

  • Able to train and help colleagues with less experience; be able to lead small projects with manageable risks and resource requirements

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 skilled 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.

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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid