Quality Compliant Manager Job

BioTouch; Columbus (GA); On-site; USD 110,000 - 160,000; Full time

Job summary

BioTouch is seeking a Quality Complaint Manager to own the complaint-handling system end to end, bridging field feedback with production. You will supervise a small team and report to the Head of Quality & Regulatory Affairs, ensuring compliance and timely action.

Based on Columbus, GA or Raleigh, NC, the role requires MDR/eMDR under 21 CFR Part 803, CAPA, ISO 13485:2016, and QMS oversight. You’ll lead investigations, manage documentation, and coordinate with regulators, OEMs, and customers to

Qualifications

• Bachelor's degree in life science, engineering, or related field.
• 5+ years in medical device quality, incl. complaint handling and MDR/eMDR under 21 CFR Part 803.
• 2+ years supervising production, kitting/assembly, or quality staff.
• Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485:2016, incl CAPA and labeling.
• Root-cause investigations and regulatory reportability within deadlines.
• Experience hosting or supporting FDA inspections and external audits.
• ASQ certification (CQA, CMQ/OE, or CQE).
• Experience with repackager/relabeller, contract manufacturer, or 3PL medical devices.
• Familiarity with Corrections and Removals (21 CFR Part 806) recall.
• ISO 13485 or MDSAP lead auditor training.
• Experience with device-plus-drug kits or combination products.

Responsibilities

• Own the complaint-handling process end to end
• Make MDR decisions and submit to FDA on time
• Lead root-cause investigations and drive CAPAs
• Trend and report complaint data to management
• Interface with OEMs, customers, and regulators
• Oversee kitting, assembly, relabeling, and line staff
• Ensure batch/device history review and product release
• Maintain GMP/GDP housekeeping and secure storage
• Ensure traceability from OEM to distribution

Skills

Root-cause analysis

Regulatory timelines

People management

Quality metrics

Documentation discipline

Audits

CAPA

Communication with regulators

Education

Bachelor's degree in life science, engineering, or related field

Tools

eQMS

WMS

Label systems

Job description

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.

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

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

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