Quality System Specialist II

Job Description

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.