Working Location:ONTARIO, RICHMOND HILL; Canada; Ontario, Toronto Workplace Flexibility:Hybrid For more than 100 years,Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives. Our fiveCore Valuesempower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus. Job Description (This is a fixed:term maternity cover position for a period of up to 18 months.) As a Market Quality Sr. Analyst OCI:OSTA team member, you will be responsible for performing timely post market activities for Canadian North American complaints that require evaluation, assessment, and/or follow:up for regulatory reporting determinations and regulatory submissions. The MQ Analyst Sr. will evaluate complaints and communicate with Field Specialists, Sales Representatives, Field Service Employees, Engineers, Technicians, Clinicians, and Customers directly as well as utilize different data sources in order to understand the facts and details around the complaints. Performs routine assignments with direction from management the supervisor as needed; requires general instruction for new or special assignments from the management. Supervisor. The MQ Analyst Sr. will maintain quality documents to ensure compliance with medical device guidance documents. The MQ Sr. Analyst should be familiar with Medical Device Quality Systems regulations including ISO 13485 the Canadian Medical Device Regulations id463__section_lib: Job Duties :Routes, process, and reviews complaints assigned daily for reportability. :Evaluate complaints against Mandatory Problem Reporting/Incident Reporting requirements to Health Canada and other applicable regulatory agencies. Prepare and submits Mandatory Problem Reports/Incident Reports in a timely manner. Files Preliminary Update and Final MPR/Incident Reports with Health Canada. :Route and process complaint information received from internal and external sources into complaint handling databases as appropriate. :Support routing and review of ancillary system sources information to ensure complaint records are accurate-facilitate exchange of information from ancillary system sources to the Complaint Handling System and supporting teams where necessary. :Provide MDR Submission team with quality records in support of preparation for submission to FDA and/or Health Canada. :Assist in due diligence and good faith effort attempt activities to drive complaint investigation closure timeliness per established local and global metrics. :Determine whether additional information is required in order to make a preliminary MDR/MPR file/no file decision. :Where appropriate in legacy complaint handling systems, review reported event description and ensure intake code is aligned with event and accurate. Review all final codes and ensure accuracy Interface with internal and external customers to obtain additional information to facilitate complaint Investigation by the manufacturer. :Documents all communication in compliance with department procedures. :Coordinates with internal and external customers, such as Operations, Service and International Olympus personnel, to support and facilitate timely failure and complaint investigation. :Monitor and prepare work in progress and safety net reports and key performance indicators regularly in support of Complaint Handling and adverse event reporting metrics. :Manage and update complaints throughout lifecycle. Document applicable elements of the complaint handling process, such as contact records with external customers, database updates, and complaint closure letters. :Interface with Health Canada and other regulatory agencies regarding compla