Quality Compliant Manager

Job Description

Job Description

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 either Columbus, GA or Raleigh, NC. Responsibilities 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 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 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 BioTouch'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 when quality criteria are not met.
Defined backup coverage and escalation path for both complaint handling and line operations. Required Skills What You Bring:
Bachelor's degree in a life science, engineering, or related field — or an equivalent combination of education and experience.
5+ years in medical device quality, including hands-on complaint handling and MDR / eMDR experience under 21 CFR Part 803.
2+ years directly supervising production, kitting / assembly, or quality staff.
Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485:2016, including CAPA, nonconforming product, and labeling controls.
Demonstrated ability to run root-cause investigations and make defensible reportability decisions under regulatory timelines.
Experience hosting or supporting FDA inspections and external audits.
ASQ certification (CQA, CMQ/OE, or CQE).
Experience in a repackager / relabeler, contract manufacturer, or 3PL handling medical devices.
Familiarity with corrections and removals reporting (21 CFR Part 806) and recall execution.
ISO 13485 or MDSAP lead auditor training.
Experience with device-plus-drug kits or combination products

What We Need:
Rigorous root-cause analysis and structured problem-solving.
Sound, well-documented decision-making under regulatory deadlines.
Floor leadership — coaching, accountability, and composure under production pressure.
Clear written and verbal communication with regulators, customers, OEMs, and staff.
High attention to detail and documentation discipline.
Fluency with quality metrics and data; comfort with eQMS and WMS / label systems.
On-site role split between an office and an active production / warehouse floor.
Occasional lifting up to [25–50 lbs] and handling of product and packaging.
Controlled-environment and GMP housekeeping requirements; PPE as required.
Periodic deadline pressure tied to regulatory reporting timelines and shipment schedules.

What You’ll Get:
Medical, Dental, Vision after 30 days
HSA and PPO plans available
Company paid Life Insurance, AD&D, and Long Term Disability
401(k) with generous company match after 90 days
Supplemental Voluntary Benefits like Short Term Disability, Critical Illness, Accident, and Hospital Indemnity
Employee Assistance Program
$500 Referral Bonus Available!