Our leading nephrology client in the Greater Boston area is searching for a Quality expert to join their Post Market Surveillance team. Come join a team that is focused on efficient quality systems that enable teams to provide the best patient centered care!
PURPOSE AND SCOPE:
Responsible for receiving, reviewing processing, and analyzing all product inquiries and product complaints for manufactured and distributed products (equipment, drug, and device) as required by applicable regulations, standards, and company policy. Provides high level customer support and serves as a subject matter expert and liaison between manufacturing facilities, distribution centers, customer/technical service and customers/patients regarding product complaints. Partners with Pharmacovigilance resources on any possible adverse event (MDR/ADE) or reportable complaints, as well as with Corporate Quality Engineering on product investigations and trends. Responds to questions and liaises with fellow department staff members regarding complaint data entry and processing.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Acts as a mentor and provides guidance to fellow staff members related to complaints on the master symptom code severity list.
- Mentors staff members regarding complaint processing.
- Acts as a go to resource for department staff members on complex complaints.
- Acts as a lead within the Post Market Surveillance department for all duties and CAPA related responsibilities as needed.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Responsible for SOP revisions/document creation/annual document review as assigned.
- Reviews/approves Complaints for file closure.
- Ensures the timely closure of all assigned complaint files in a consistent and timely manner, and ensures that all pertinent information is contained within the file prior to closure.
- Monitors and reports on complaint closure metrics as required.
- Ensures complaints are processed in a uniform and timely manner, whether they are of equipment, drug, or device origin.
- Ensures oral complaints are documented upon receipt using good documentation practices (GDP).
- Responsible for receiving, reviewing, entering, and evaluating data into the Compliant Management Database regarding customer/patient product inquiries and complaints and further processing complaint files.
- Interfaces with Customer Service and customers/patients to gather additional information required for complaint investigations, including the retrieval of product samples.
- Provides training during orientation and on-boarding of new staff.
- Applies knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance MDR/ADE reporting decision process within regulatory timeframes.
- Responsible for the completion of MDR/ADE decision trees and is able to complete MDR submissions.
- Understands the Field Alert Reporting (FAR) process and evaluate, distinguish and recommend complaints for FAR reporting.
- Recognize complaint trends and is able to present related information to management.
- Provides coding support and reviews and updates complaints in the Compliant Management Database
- Determines product and incident complaint codes and responds to questions regarding complaint coding from staff members.
- Notifies customer of receipt of product inquiry/complaint and provides preliminary support as required. Refers complex inquiries to supervisor/manager, as needed.
- Prepares other customer communication (response letters, acknowledgement letters), as appropriate.
- Partners with sales, marketing, and manufacturing departments to resolve product problems and provides feedback to customers as needed.
- Responsible for maintaining complaint files within a secured environment.
- Ensures complaint responses and any replies to the complainant is documented in the complaint file when applicable.
- Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
- Interfaces with Corporate Quality Engineering and manufacturing sites for product investigations and trend reporting.
- Completes MDR/ADE submissions for all reportable malfunctions/serious injuries to include review of complex post medical record review files.
- Acts as a MDR/ADE pre submission reviewer.
- Strives to meet Accuracy Goals (95% accuracy goal).
- Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
- Assists management with work flow specialist assignments.
- Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
- Networks with key contacts outside of area of expertise.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists with various projects as assigned by a direct supervisor.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
- Bachelor's Degree required, preferably in a healthcare related field; Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 8 – 12 years of related experience in complaint handling in the healthcare/device industry with exposure to medical device quality system regulations; understanding of drug/device safety requirements; with an Advanced Degree 6 years of experience may be acceptable.
- Solid understanding of regulatory obligations for compliance within scope of department (21 CFR 820.198 and 21 CFR 211).
- Strong interpersonal and decision making skills
- Knowledge based PC computer skills essential, such as industry recognized complaint management systems, crystal reporting, MS Access and Excel.
- Understanding of medical terminology
- Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
Title 21 Of The Code Of Federal Regulations