Quality Control Manager, Medical Devices (Class III)

4 C Medical Technologies; Maple Grove (MN); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Medical

Dental

Vision

FSA

Life Insurance

401(k)

Paid Holidays

PTO

Parental leave

Job summary

4C Medical Technologies is seeking a Quality Control Manager to lead day-to-day QC operations across tissue processing, valve assembly, Nitinol frame processing, and cleanroom packaging. You will supervise five QC professionals and drive inspection, testing, and release activities while ensuring audit readiness as the company progresses toward regulatory approvals in the U.S., Europe, and Canada.

The role requires overseeing non-conformance management, CAPA, and robust documentation, with a

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related technical field.
• 7+ years in quality control/quality engineering/mfg quality in medical devices.
• Experience with FDA-regulated manufacturing and 21 CFR Part 820; ISO 13485 familiarity.
• Experience leading investigations, CAPA, and root-cause analyses.
• Experience mentoring and developing quality professionals.
• Strong understanding of inspection, testing, process controls, and quality systems in manufacturing.

Responsibilities

• Oversee daily QC inspection, testing, and release for raw materials, in-process, and finished sterile devices.
• Drive quality oversight for tissue-to-frame sewing and valve assembly processes.
• Maintain audit readiness with proper documentation, traceability, and cleanroom criteria.
• Own investigations, non-conformances, CAPA, and deviations.
• Lead QC team development and partner on training matrices for valve sewing/assembly.
• Oversee environmental monitoring and bioburden testing on production lines.

Skills

Quality leadership

FDA 21 CFR 820

CAPA & investigations

Documentation control

Environmental monitoring

Team mentoring

Valve sewing/assembly knowledge

Education

Bachelor’s degree in Engineering/Life Sciences/Quality

Tools

FDA regulations awareness

Job description

4C Medical Technologies is seeking a Quality Control Manager to lead day-to-day QC operations across tissue processing, valve assembly, Nitinol frame processing, and cleanroom packaging. You will supervise five QC professionals and drive inspection, testing, and release activities while ensuring audit readiness as the company progresses toward regulatory approvals in the U.S., Europe, and Canada.

The role requires overseeing non-conformance management, CAPA, and robust documentation, with a