Job Description Summary

The Sr. Quality System Specialist is accountable for support of the continued development, improvement, and implementation of the Quality
Systems. This position actively participates in quality guidance, product resolution decisions, and project teams for process improvement and
continuous improvement activities.

Job Description

Job Responsibilities:

• Maintains quality system metrics (electronic dashboard) and quality system documents.
• Consistent application of quality system standards to assigned quality system area.
• Develops solutions to routine assigned activities of moderate scope & complexity.
• Follows applicable Company/Unit procedures and may make updates to procedures and policies.
• Works within and across functions for assigned quality systems.
• Working knowledge of quality systems regulatory requirements and application to Company/Unit requirements.
• May perform other duties as required.

Education and Experience:

• Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills:

• Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).
• Working knowledge of applicable Corporate and/or Unit requirements.
• Contributes to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Knowledge of data analysis and reporting (electronic dashboards) with the ability to collaborate with process owners for issue resolution is highly desirable.
• Able to prepare or revise policies and procedures.
• Can independently determine and develop approach to solutions.
• Ability to design and perform development while working independently within defined parameters under minimal supervision.
• Can provide guidance and work direction to lower level project developers.
• Can develop solutions to routine assigned activities of moderate scope & complexity.
• Experience with BD software systems utilized in the Quality Systems is desirable (SAP, Trackwise, PEGA, Goldfire).
• High proficiency in Microsoft Excel (including Macros), Power BI, Qlikview is highly desirable.
• High proficiency in Microsoft Word / Document Management is highly desirable.
• Transactional Six Sigma Green Belt desirable.

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift