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 MDR's into the eMDR system and other projects as assigned.
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
Minimum Associates Degree.
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.
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
BD (Becton, Dickinson And Company)