Quality Compliant Manager Job
About the role
Why You'll Love This Job Our Mission Touch Lives. Improve Outcomes. BioTouch is a single-source, international provider for all mission-critical kitting and logistics needs. We partner with a wide range of medical facilities and healthcare providers to bring a higher level of care to healthcare delivery. Simply put, we are doing our part in the healthcare specialty logistics arena! The Role The Quality Complaint Manager will solely own the complaint-handling system end to end, while directly supervising the day-to-day operation and line staff for our medical kitting business unit. The position sits where the voice of the customer meets the production floor: the manager who investigates and reports complaints also leads the team whose work those complaints concern, closing the loop between field feedback and corrective action. The role reports to the Head of Quality & Regulatory Affairs and carries both independent quality-system authority and direct people-management responsibility. Position can be located in Columbus, GA or Raleigh, NC.
Responsibilities
- Own the complaint-handling process end to end
- Make and document medical device reportability decisions; prepare and submit MDRs to FDA within required timeframes
- Evaluate, record, and where required report corrections and removals
- Maintain complete, legible, and retrievable complaint files and records with data integrity and defined retention.
- Lead and document root-cause investigations; initiate and link CAPAs where complaint severity or trends warrant.
- Trend and analyze complaint data; present metrics, signals, and escalations into management review.
- Serve as the complaint interface with OEMs / specification developers and customers, and execute the responsibilities assigned to BioTouch