Quality Compliance Manager MDR & Production Oversight

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

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