7 days old

Quality Assurance

Bengaluru, KA 560002
  • Provide guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
  • Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development, agreeing and planning for requirement management and approving documentation.
  • Collaborating closely with R&D, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities.
  • Take part in the Quality assurance activities as an active member of relevant project teams.
  • Assessing overall product risk by facilitating the use of risk management tools and contributing to the risk management evaluations.
  • Participating in quality training activities.
  • Keep up to date knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
  • Provide support in driving IDC specific Quality initiatives

    Demonstrate Danaher values and adopt DBS tools

    • University Degree in Science or equivalent
    • Fluent in English €“ written and verbal
    • 2-4 years spent within a highly skilled quality team in a software orientated product range
    • An ability to effectively communicate verbally and in written format.
    • Proficiency using Microsoft Office suite.
    • Experience of working within a global, matrix organization, preferably in the software development industry
    • Knowledge on ISO 13485, 21CFR11, 21CFR820 etc.

      Note: ISO13485 lead auditor certification is an added advantage.

    • Knowledge on Qualification/validation of tools/Non-Product Software Validation.
      • Experience in software lifecycle process (requirements, design, code, and test) for a regulated environment
      • Ability to understand basic technical terms and concepts.
      • Evidence of a strong work ethic, ability to work independently with little supervision, and share workload in team settings.
      • Strong interpersonal skills - can professionally manage issues and excels in settings requiring teamwork.

        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 €œEEO is the Law€ poster is available here.","industry":"Medical Device


Posted: 2020-05-21 Expires: 2020-06-20

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Quality Assurance

Bengaluru, KA 560002

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