Glidewell Dental
Complaint, Lead
Pay$35.00 - $45.00 / hour
LocationIrvine/California
Employment typeFull-Time
This job is now closed
Job Description
- Req#: o6K1vfw6?nl=1
- Leads the daily activities of the complaints department.
- Maintains QMS documentation required for complaint processing compliance with 21 CFR part 820.198 and MDSAP program.
- Organizes reporting of department operations to track department status.
- Files FDA Medical Device Reporting (MDR) and Health Canada incident reports.u00A0 u00A0
- Evaluates event(s) to determine if it qualifies as a complaint.u00A0
- Maintains and completes complaint files for all customer complaints according to procedures.
- Assesses complaint information provided; conducts additional investigations and escalates complaint to appropriate parties as needed.
- Compiles adverse event investigation information; summarizes investigation, production analysis, imaging review, instructions for use (IFU), and other relevant labeling and/or training materials; formulates conclusions.
- Interfaces with customers and collaborates with various departments and management.
- Manages customer relationships and expectations during course of complaint investigation.
- Serves as resource for team members.
- Serves as subject matter expert (SME) of Quality Systems for complaint handling and regulatory reporting.
- Monitors complaints regulatory reporting requirements to ensure timeliness of submissions.
- Evaluates complaints for adverse event reporting as applicable.
- Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA.
- Verifies decisions for Vigilance report not required and u201CMDR report not requiredu201D determinations.
- Closes complaint files when necessary.
- Reviews potential reportable events to determine if regulatory filings are required.
- Submits Regulatory Reports for US and OUS.
- Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
- Coordinates escalation to Medical Reviewer(s) for decisions regarding potential for serious injuries based on assessed risks.
- Escalates complaints when new failure modes are encountered.
- Maintains awareness of new products and government regulations and requirements.
- Documents and completes complaints in timely manner.
- Prepares and submits final customer correspondence as required.
- Performs other related duties and projects as business needs require at direction of management.
- Bacheloru2019s degree in science, engineering, or equivalent relevant experience preferred.
- Minimum five (5) years of experience within complaint handling department or equivalent.
- Minimum one (1) year of experience as a Lead, preferred.
- Advanced medical device experience involving medical device complaint files, inspections and, quality records required.
- Advanced understanding and interpretation of domestic and international complaint handling and reporting requirements required.
Essential FunctionsEducation and Experience:
About the company
Glidewell Dental's mission is to drive down restorative costs and expand patient access to affordable dentistry. Glidewell Dental offers dental products and services in partnership with dentists, dental laboratories and manufacturers to promote and restore clinical health. One of the largest dental labs in the world and a medical device manufacturer, the company operates from four locations worldwide.
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