Quality Control Lead - Medical Devices

100Hires, Inc.; Berlin (CT); On-site; USD 60,000 - 90,000; Full time

Job summary

100Hires, Inc. seeks an experienced Quality Control Leader to oversee QC functions in a medical device manufacturing environment. The role requires maintaining ISO 13485 documentation and performing inspections on machined components using calipers, micrometers, and related equipment.

The candidate will train and coach QC personnel, align workload, and ensure GDP/GMP standards are followed throughout DHRs, DMRs, and final lot release. Strong attention to detail and teamwork are essential.

Qualifications

• Must read blueprints, specifications and procedures accurately.
• Experience with GMP/ISO quality systems is preferred.
• Detail oriented with high accuracy in measurements.

Responsibilities

• Lead quality control team and align workload across shifts.
• Perform incoming, in-process, and final inspections per procedures.
• Maintain ISO 13485 documentation and GDP guidelines.
• Record nonconformities and drive corrective actions.
• Utilize ERP and QMS to document inspections and traceability.
• Train staff on inspection methods and equipment usage.

Skills

Blueprint reading

Dimensional inspection

Visual inspection

Measurement equipment handling

MS Office

Team leadership

English communication

Education

High school diploma, GED or equivalent

Tools

Comparator

Vision System

CMM operation

Job description

100Hires, Inc. seeks an experienced Quality Control Leader to oversee QC functions in a medical device manufacturing environment. The role requires maintaining ISO 13485 documentation and performing inspections on machined components using calipers, micrometers, and related equipment.

The candidate will train and coach QC personnel, align workload, and ensure GDP/GMP standards are followed throughout DHRs, DMRs, and final lot release. Strong attention to detail and teamwork are essential.