Quality Compliant Manager Midland, GA

Touch Lives. Improve Outcomes. Bio Touch 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 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 either Columbus, GA or Raleigh, NC.

Your Impact:

Primary Responsibilities

• Own the complaint-handling process end to end
• Make and document medical device reportability decisions; prepare and submit MDRs to FDA within required time frames
• 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 Bio Touch under quality / technical agreements.
• Ensure the regulatory timeliness and audit-readiness of all complaint and MDR records.

Operations Oversight

• Directly supervise the day-to-day kitting, assembly, repackaging, and relabeling operation and its line staff — scheduling, work assignments, and throughput.
• Enforce labeling and packaging controls including label accountability / reconciliation and documented line clearance before and after each job to prevent product and label mix-ups.
• Review and approve batch / device history records; authorize product release against defined acceptance criteria.
• Ensure forward and backward lot traceability from the incoming OEM lot through the repack / relabel lot to distribution.
• Oversee control of nonconforming product — identification, segregation, documented disposition, and any rework.
• Maintain GMP / GDP housekeeping, controlled storage conditions, FEFO, and workplace organization on the floor.
• Manage staffing levels, coverage, cross-training, and coaching to meet quality and output targets.
• Partner with planning and customer service to balance on-time delivery against quality requirements.

Quality System & Compliance

• Operate within Bio Touch's QMS under 21 CFR Part 820 (QMSR) incorporating ISO 13485:2016, and support MDSAP where applicable.
• Maintain document and record control for owned procedures and records.
• Deliver and document training and competency for complaint-handling and kitting personnel.
• Support internal and external audits and FDA inspections; host, respond to, and close findings within the role's scope.
• Feed complaint and customer-feedback data back into operations to drive corrective action and continuous improvement.
• Contribute to quality objectives, management review inputs, and improvement initiatives.

Supervisory Responsibilities

• Direct supervision of staff and coordinators
• Hiring input, performance management, scheduling, and development of direct reports.
• Authority to hold product and stop a job…