Quality Systems Complaint Analyst
The Quality Systems Complaint Analyst is responsible for performing complaint handling activities including routine complaint investigations and adverse event reporting for the purpose of ensuring compliance with USA and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience. This position also supports Quality Systems by generating complaint trending reports.
Essential Duties & Responsibilities
· Create incident/adverse event (complaint) files as reported. This includes logging in the incident/event, generating initial report(s), notifying Quality and Regulatory Management of the incident/event, completing customer correspondence (i.e., Acknowledgement Letters), and updating logs as required.
· Perform routine complaint investigations. This includes verifying that the hazard has been addressed in product/process Risk Management files, writing an investigation report based on findings, and completing all required documentation for file closure. This may involve interaction with hospital personnel, sales representatives, distributors, customers, and other Aziyo employees to obtain all required information to complete the investigation.
· Assist Quality Management with the assessment, creation & submittal of Adverse Event Decision Trees and MDR/Vigilance Reports for each adverse event (complaint) file.
· Maintains the Medical Device Reporting system using FDA eMDR (WebTrader) gateway and any other applicable government electronic regulatory submission tools.
· Responds to an agency Request for Information (RFI) on any required MDRs/events.
· Generate monthly and quarterly complaint/adverse event trend reports.
· Review literature articles for events related to Aziyo Biologics products.
· Supports audit activity related to the complaints/events topic.
· Administrate histology requests.
BA or BS degree required. Degree in Quality, Science, Engineering, or a BSN/RN with Licensure is preferred.
Experience and Skills
Work Experience Required:
· Candidate must demonstrate a minimum of 3 years of work experience in the Medical Device Industry performing Quality Systems, Quality Assurance, and/or Quality Engineering support activities.
· Candidate must have previous experience with complaint handling, adverse event/vigilance reporting, and or quality investigations.
Specialized Skills, Knowledge:
· Proficient in MS Office applications (Word, Excel, PowerPoint, Outlook).
· Knowledge of FDA 21 CFR Part 820, Quality Systems Regulations, 21 CFR Part 803, Medical Device Reporting, ISO 13485 requirements, HIPAA, and any other requirements for jurisdictions the Aziyo products are distributed in.
· Possess understanding of risk management concepts and is capable of assessing product risks.
· Able to make judgment calls using combination of knowledge of regulations, knowledge of device technology, clinical experience, and critical thinking.
· Full understanding of Good Manufacturing Practice (GMP) preferred.
· Experience with animal tissue devices preferred.
· Willingness to be flexible and adaptable to changing priorities.
· Ability to perform detail-oriented work with a very high degree of accuracy.
· Ability to read and interpret documents such as safety rules, instruction manuals and write routine reports and correspondence.
· Familiar with standards for laboratory safety (appropriate gloves, glasses & clothing to handle lab materials safely).
· None Required
· Able to investigate returned materials in lab conditions by use of vision and hands to handle, measure, photograph or feel product and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. The employee is regularly required to sit and talk or hear.
· This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids.
Quality Management System (QMS) Responsibilities
Positions with QMS responsibility are listed in FT-2160A Quality Management System (QMS) Responsibilities Matrix. QMS Process Ownership:
No QMS ownership responsibilitiesQuality Subsystem(s): Complaint processing & complaint trending
QMS Process Ownership Responsibilities: 1) Monitor QMS subsystem(s) to ensure compliance to SOP requirements. 2) Participate in QMS activities associated with the subsystem(s) (meetings, activities, etc.). Act as auditee for internal audits associated with the QMS subsystem(s). 3) Review the performance and health of the QMS subsystem(s) with Quality Management and/or Management Representative prior to management review meetings. 4) If identified, inform the Management Representative
of any issues or potential deficiencies associated with the subsystem(s).