Sr.Quality System Specialist
- Bangalore, Karnataka
- Permanent
- Full-time
Systems. This position actively participates in quality guidance, product resolution decisions, and project teams for process improvement and
continuous improvement activities.Job DescriptionJob 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.
- 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.
- 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.