San Jose based Visby Medical is an ambitious, well-funded, and fast-paced early-stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way infectious disease is tested and treated.
We are developing a tenacious team with the deep industry expertise of researchers, biologists, designers, and engineers that is back-stopped by world-class operations and administrative resources. If you enjoy tackling challenging problems, are passionate about your work product, and want to join a collaborative ownership team that is aiming to leave a lasting positive legacy in the healthcare industry, please consider the following Complaint Handling Supervisor opportunity.
The Complaint Supervisor is responsible for all aspects of the Complaint Management process. The role will supervise a post-market surveillance team who execute the complaint handling process. The Post-Market Surveillance processes are activities mainly related to patient safety risk assessments, Medical Device/Vigilance reporting, coordinating the Customer Complaints process, and support compliance. With limited supervision, assist the organization in the required areas as listed in General Responsibilities.
- Supervise a complaint handling group.
- Manage the handling, investigation and resolution of all product performance complaints and patient-related field events in a manner that complies with regulatory requirements.
- Manage the complaint handling process, including but not limited to complaint procedures and training of post-market surveillance team.
- Champion the efforts to streamline complaint handling process; improve visibility and issue resolution.
- Establish and monitors complaint metrics and drives process improvements based on performance trends.
- Drive product quality improvements and support quality-based processes to ensure the high-quality products and solutions, as well as compliance with all applicable regulations and requirements.
- Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions.
- Review completed complaint files to ensure compliance to business requirements as well as regulatory requirements.
- Initiate and support corrective or preventive actions as needed.
- Support and participate in internal and external audits, risk management summaries and health hazard evaluations.
- Ensure timely completion of MDR and Vigilance reporting, as well as initial, supplemental and final incident reports to regulatory authorities within specified timelines.
Education and/or Experience
- Bachelor s degree, plus a minimum of 5 years of related experience in the in-vitro diagnostics or medical device industry.
- Minimum of 5 years of supervisory experience in Complaint Handling processes.
- Must be able to communicate appropriately and adequately to all management levels, including group presentation experience.
- Excellent written and interpersonal communication skills.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.