Position : Quality System Specialist I Location : Sandy, UT Duration : 3 Months Contract Start Time : 8:00 AM End Time : 5:00 PM Total Hours/week : 42.50( Mon- Fri)
Preferred Bachelor’s degree in Biological or Life Sciences, however associates degree with applicable experience will be considered.
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. Minimum Associates Degree 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
As directed by the Sr. Manager Quality the Quality System Specialist II is accountable for review of complaints for MDR reportability and completion of MDR’s into the eMDR system as required.
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 report ability (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