Quality Specialist

VAPOTHERM, INC.•Mesquite, TX

15d

About The Position

The Quality Specialist is responsible for complaint and regulatory reporting system activities, including logging, investigating, and closing complaints. The role also assists with responses to regulatory inquiries about complaints, supports the calibration of devices and equipment, and performs limited incoming inspection activities. The position oversees the service facilities calibration program and coordinates regular calibration with internal teams and external vendors. It also supports Quality Management System activities, including post-market surveillance (PMS) reporting, Engineering Change Orders (ECOs), and other QMS updates.

Requirements

Associate degree or higher in science or a related field preferred.
0–3 years of experience in the medical device, pharmaceutical, or regulated industry.
Strong documentation skills, including the ability to prepare clear, accurate, well-organized reports.
Proficiency in Microsoft Office Suite, especially Excel.
Excellent verbal and written communication skills.
Strong attention to detail, particularly during periods of increased workload.
Ability to work in a service or production environment.
Occasionally lift and move objects weighing up to 25 pounds.

Nice To Haves

Some experience handling and investigating complaints.
Some experience with technical troubleshooting.
Familiarity with root cause analysis methodologies.
Hands-on experience with consumer hardware or medical device manufacturing or testing.
Strong technical ability to understand device operation, including mechanical parts and electronic components.
Experience in the medical device industry.

Responsibilities

Manage complaint files, including opening files, evaluating complaints for reportability in the United States and worldwide, and preparing files for closure.
Investigate device failures independently and as part of a team, and document investigation findings.
Perform root cause analysis and identify improvement opportunities.
Follow up with in-house personnel about complaint investigation outcomes, including the manufacturing and R&D teams.
Assist with responses to Regulatory Authorities.
Oversee and maintain the service facilities calibration program to ensure equipment meets regulatory requirements.
Coordinate regular calibration of tools and equipment with internal teams and external vendors.
Assist with limited incoming inspection activities for established supplier controls.
Participate in post-market surveillance activities, including organizing the organization’s PMS report.
Support Engineering Change Orders and other QMS updates as needed.