Quality Manager - Medical Devices & Regulatory Compliance

100Hires, Inc.; Attleboro (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

100Hires, Inc. seeks a Quality Manager to lead quality assurance for precision machined medical components in Attleboro, MA. The role ensures compliance with ISO 13485, ISO 9001, FDA, ITAR, and customer specs, while driving process control and continuous improvement.

The candidate will manage CAPA, audits, metrology, GD&T, and measurement systems, and lead development of inspection plans and work instructions in a regulated manufacturing environment.

Qualifications

• Degree or equivalent in a technical field required.
• 5+ years in regulated manufacturing quality roles.
• Experience with ISO 13485, ISO 9001, FDA, and ITAR audits.

Responsibilities

• Lead QMS and regulatory compliance activities.
• Oversee metrology, calibration, GD&T, print reading.
• Lead supplier and internal audits; CAPA management.
• Collaborate with manufacturing and engineering to resolve quality issues.

Skills

ISO 13485

ISO 9001

ITAR compliance

FDA regulations

Metrology

GD&T

CAPA

Leadership

Continuous improvement

Education

Bachelor’s degree in Quality/Engineering/Manufacturing

Tools

CMM/Optical inspection

Job description

100Hires, Inc. seeks a Quality Manager to lead quality assurance for precision machined medical components in Attleboro, MA. The role ensures compliance with ISO 13485, ISO 9001, FDA, ITAR, and customer specs, while driving process control and continuous improvement.

The candidate will manage CAPA, audits, metrology, GD&T, and measurement systems, and lead development of inspection plans and work instructions in a regulated manufacturing environment.