Product Complaints Supervisor
Main Objectives: Lead and motivate a staff of Product Surveillance Specialists with two primary functions:
Process medical device complaints in accordance with 21 CFR 820.198 and ISO 13485:2016.
Process customer and employee inquiries via phone and email for product repair and pricing matters.
Essential Duties and Responsibilities:
Supervise the day to day activities of a staff of Product Surveillance Specialists.
Motivate and empower the team to initiate and engage in continuous improvement initiatives and to strive to take ownership of their processes and workflows.
Foster a team environment where individuals come together in a willing manner to help each other with problem solving, workflow issues, and overcoming various daily roadblocks to success.
Assign projects, schedule work assignments, and train new employees on how to properly document complaints, conduct investigations, evaluate investigations, and review complaints for closure.
Meet departmental process efficiency goals for all product complaints and repair requests from receipt to closure.
Interface with external customers, distributors, healthcare professionals, internal engineering, marketing, regulatory, accounting and legal departments to accomplish goals.
Cover department functions during times of short staff.
Be responsible for assisting with product recalls as directed by Senior Leadership; own the product recall process from initiation to conclusion and provide status updates to Senior Leadership.
Lead change management projects to keep pace with new work flows and increased volume.
Develop custom reports for regulatory reporting, Management Review, and trend analysis.
Identify and present quality issues with risk based prioritization.
Research and resolve business transaction conflicts with consistent results.
Provide input to written procedures and communicate any systemic issues to the department manager.
Maintain an up to date knowledge of regulations affecting the department.
Provide routine status reports related to quality and efficiency goals.
Administer performance reviews and disciplinary action when necessary.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Working knowledge of ISO, FDA, MDD and JPAL quality requirements.
Excellent customer service skills. Ability to maintain a positive outlook and to frame challenges and issues in a beneficial manner. Leadership qualities dealing with adversity, overcoming individual challenges for the good of the team, strategic thinking mentality.
Proficiency in Microsoft Office applications is required, with functional and above average experience with Microsoft Excel strongly preferred. Experience working with customer support, CRM, or Quality Management System applications is preferred. Examples include Agile, SalesForce,Trackwise, SmartSolve, CATSWeb.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.