Job Description Summary

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

Additional Locations

Work Shift