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Job Information

BD (Becton, Dickinson and Company) Quality System Specialist II in Sandy, Utah

Job Description SummaryAs directed by the Manager/ Sr. Manager Quality, the Quality System Specialist II (QSSII) is accountable for review of complaints for MDR

reportability, completion of Medical Device Reports into the eMDR system and other projects as assigned.

Job Description

Responsibilities

  • Maintains and resolves assigned tasks through the complaint database.

  • Performs tasks, of moderate complexity, within planned schedules and timelines, supporting audits, participating on project

  • teams, ensuring documentation compliance, handling processes and assigned tasks related to customer complaints and MDR’s

  • Follows applicable Company / Unit procedures and may revise policies and procedures when asked upon.

  • Develops solutions to assigned activities of limited scope (e.g. Document change, Complaint file entry, MDR documentation, etc.).

  • Prepares reports and summaries as directed, including quantitative and qualitative analysis.

  • Completes MDR DT’s.

  • Completes MDR’s into the eMDR system.

  • Knowledge of decisions regarding reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.

  • Closely monitors quality, completeness and timeliness of MDR DT completion. Reviews, tracks, trends, analyzes and reports on MDR data

Requirements

  • Minimum Associates Degree in Nursing or Sciences.

  • Understanding of quality science, clinical usage of devices, knowledge of quality systems, and strong performance management skills.

  • Excellent communication skills

  • Excellent team and interpersonal skills.

  • Detail orientated.

Additional and Preferred Skills and Qualifications

  • Bachelors degree in Science, Nursing, Mathematics or Engineering preferred..

  • Knowledge in regulations for Medical Device Reporting (MDR) preferred.

  • Duties are very complex in nature and pertain to the overall interaction of many Quality Systems

  • Must be able to multitask and prioritize effectively to meet business goals and departmental objectives

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race,

color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional

or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work LocationUSA UT - Sandy

Additional Locations

Work ShiftUS BD 1st Shift 8am-5pm (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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