Quality Specialist

SUMMARY OF POSITION This position is responsible for complaint and regulatory reporting system activities including logging, investigation and closure of complaints. Additional responsibilities include assisting with responding to regulatory inquiries on complaints as required. This position will provide support for maintaining calibrated devices and some incoming inspection activities. PRIMARY RESPONSIBILITIES Complaint Investigation Activities Manage complaint files, including opening files, evaluating complaints for complaint reportability in the US and worldwide, and preparing files for closure Perform device failure investigations independently and as part of a team and document. Perform root cause analysis and identify improvement opportunities. Follow up with in-house personnel regarding complaint investigation outcomes, including communications with Vapotherm’s manufacturing team and R&D team. Assist with responses to Regulatory Authorities Calibration Oversee and maintain the service facilities calibration program to ensure all equipment is compliant and meets regulatory requirements. Coordinate with internal teams and external vendors to perform regular calibration of tools and equipment. Quality Management System (QMS) Support Assist in limited incoming inspection activities for established supplier controls. Participate in PMS activities, including but not limited to, the organization’s PMS report. Support Engineering Change Orders (ECOs) and other QMS updates as needed POSITION REQUIREMENTS Education and Experience Associates Degree or higher in Science or related field preferred. Minimum of 0-3 years of experience in the medical device, pharmaceutical, or regulated industry. Skills and Competencies Needed Strong documentation skills, with the ability to prepare clear, accurate, and well-organized reports. Some experience handling and investigating complaints preferred. Some experience with technical troubleshooting. Proficiency in Microsoft Office Suite especially excel. Excellent verbal and written communication skills. Maintain strong attention to detail, especially during times of increased workload Skills and Competencies Nice to Have Familiarity with root cause analysis methodologies. Hands-on experience with consumer hardware or medical device manufacturing or testing. Strong technical ability to understand the workings of devices, including mechanical parts and electronic components is preferred. Experience in the Medical Device industry Physical Demands Ability to work in a service/production environment. Occasionally required to lift and move objects weighing up to 25 pounds.