Quality System Specialist II

Position

Quality System Specialist II

Location:

Sandy, UT

Duration: 12+ Months Contract

Total Hours/week: 40.00

As 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.

• 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 MDRs.
• Follows applicable Company/Unit procedures and may revise policies and procedures when requested.
• 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 and MDR’s into the eMDR system.
• Applies knowledge of decisions regarding reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
• Monitors quality, completeness and timeliness of MDR DT completion; reviews, tracks, trends, analyzes and reports on MDR data.

• 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 and interpersonal skills.
• Detail oriented.

• Bachelor's degree in Science, Nursing, Mathematics or Engineering.
• Knowledge of regulations for Medical Device Reporting (MDR).
• Experience with complex duties involving multiple Quality Systems.
• Ability to multitask and prioritize effectively to meet business goals and departmental objectives.