This position manages the Field Assurance Department from a global perspective and provides a high degree of confidence that all product complaints received on products manufactured and/or marketed by our Urology & Critical Care (UCC) division and any of its business groups are documented and maintained in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Business Unit, and International regulations, policies and procedures.
- Establish the systems and processes for receiving and handling complaints.
- Establish the systems and processes, including the assessment tools for determining and reporting eMDRs.
- Establish a process by which complaints in the post market surveillance studies and clinical studies are entered in the complaint system.
- Coordinates the review, investigation, and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations.
- Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
- Interprets corporate policies and regulations as they relate to Field Assurance, and prepares and implements Business Unit procedures for conformance, when necessary.
- Prepares departmental budget and operates within the budget.
- Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the closure of the file.
- Manage complaint turnaround times and corrective action follow-up.
- Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
- Serves as a contact for responding to FDA or any other regulator’s (BSI, country competent authorities, etc) inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by UCC.
- Ensures that all complaints on products marketed by UCC and any of its associated business groups are received, documented, analyzed, and trended in accordance to Corporate and Business Unit policies and procedures, and applicable regulations.
- Manage the Field Assurance subteams, including but not limited to, Laboratory Investigation team, Clinical Risk Evaluation, and product specific field assurance teams for spontaneous or legal complaint types to ensure the complaints are managed from intake to closure including reporting requirements, investigation and closure.
- Manages the interaction with 3rd party service supplier who conducts portions of the complaint process on behalf of UCC. Provides oversight to their performance to ensure that all requirements of the complaint handling process are being met via objective service measures.
- Serves as the representative for Post-Market Surveillance subsystem in internal and external audits. Responsible for responding to, investigating and remediating any audit nonconformances identified.
- Ensures trending reports are generated and presented to upper management as required.
- Coordinate worldwide exchange of complaint information.
- Facilitate the communication of complaint trends to business franchise teams to ensure that compliance and business requirements are met.
- Monitor user-related complaint trends. Coordinate customer in-servicing and follow-up with Sales Force and Clinical Educators.
- Based on customer experience, provide input as needed into the development of sales force training materials.
- Interacts with Corporate Legal in responding to litigation requests, reimbursement requests, and evaluation results requests for UCC.
- When required, respond to interrogatories, collection of documents and participate in depositions.
Complaint Handling and Reporting Responsibilities
- Receive complaints and follow-up to collect relevant information from the user.
- Arrange for the return of complaints samples.
- Direct the investigation of complaints including any bench testing.
- Review existing P/DFMEAs for updates, as required.
- Make clinical severity and risk assessments, classify and assign FDA defect code. Where appropriate and as necessary, discuss complaints and clinical severity with the Medical Director.
- Determine whether a product complaint is a malfunction or serious injury that requires reporting to the FDA and ensure reporting within the required time frame.
- Where necessary, handle FDA inquires of complaints.
- Interacts with international facilities with reporting responsibilities to BMD in establishing standardization of complaint handling and MDR/vigilance compliance.
- Approve all International Vigilance decision trees.
- Where the complaint should be a Competent Authority Report, create the vigilance report, if required, provide any CA inquiries.
- Maintain all required records for the complaints and/or eMDR Reports.
- Where necessary, assign CAPA investigation.
- Train customer facing staff, such as sales staff, on the complaint system and internal reporting procedure.
- Lead training on GMPs/complaint handling for sales representatives.
- Conduct CAPA or supplier performance investigation, where applicable if complaint handling system performance indicators warrant improvement.
- Understanding of current business systems and technologies, including proficient computer skills
- Solid understanding of current industry, quality and company trends.
- Ability to organize and analyze data and identify trends to offer solutions.
- Ability to interpret GMPs, regulations, corporate and company policy.
- Detailed understanding of clinical application and device function; clinical depth to make business decisions.
- Ability to apply tactical regulatory and business knowledge.
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, telephone manner, professionalism, coaching, influencing, and team building.
- Strong listening and assessment skills, including the ability to manage people and control stress team dynamics
- Strong questioning & problem-solving skills.
- Detail oriented, committed to accuracy, efficiency, and consistency, inclusive of maintenance of department records
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
- Maintaining a calm and positive approach to negative issues and resolve day-to-day problems associated with managing the personnel and duties of the Field Assurance Department.
EDUCATION and/or EXPERIENCE
- Four-year degree in science or technical field; MS in engineering or technical science preferred
- Minimum 10 years of demonstrated ability with FDA/ISO 13485 regulated industry
- Minimum 5 years experience in medical device Quality systems; preferable to be inclusive of experience with specifically with Post-Market Surveillance quality subsystem, inclusive of complaint handling, MDR/adverse event reporting, and complaint investigations.
- Minimum 7 years’ managerial or supervisory experience with proven track record of successful development of personnel.
Base Salary - $120,000 to $130,000
Seniority Level - Mid-Senior
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally