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Document Quality Specialist - Medical Devices
Ref No.: 18-27428
Location: Sandy, Utah
Title :Quality System Specialist II
Duration : 6 months- could be extended to 12 months.
Location: Sandy, UT



• 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 as required 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

• Additional Job Description / Requirments
• Understanding of quality science, clinical usage of devices, knowledge of quality systems, and strong performance management skills.
• Excellent communication skills
• Knowledge in regulations for Medical Device Reporting (MDR)
• Excellent team and interpersonal skills.
• Detail orientated.
• 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
• Tech writing skills
• Medical device or industry exp preferred

*** must have a minimum of an associate's degree. Education preferred in a science or engineering related discipline.