Remote Medical Device QA Lead Auditor

G-MED NORTH AMERICA, Inc.; Rockville (MD); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

401K

Bonus

Telework

Job summary

GMED North America is seeking a Lead Auditor for medical devices to conduct ISO 13485/MDSAP audits and CE marking activities. This is a home-based role with travel to client sites, reporting to the Unit Manager.

The ideal candidate has hands-on technical experience in active and non-active devices, plastics and metals, with at least four years in R&D, manufacturing, testing or auditing of medical devices and two years in quality management. Remote work is possible.

Qualifications

• Bachelor’s degree in relevant fields as required.
• Min 4 years hands-on experience in medical devices (R&D, manufacturing, testing or auditing).
• At least 2 years in quality management under regulatory standards.

Responsibilities

• Audit client sites and prepare reports per GMED standards.
• Assess Quality Management Systems against ISO 9001:2015 and ISO13485:2016.
• Coordinate travel, scheduling and client communication.

Skills

Audit leadership

ISO 13485

MDSAP

CE Marking

Quality mgmt

Regulatory

Education

Bachelor in Computer & Software Technology

Biology

Chemistry

Biochemistry

Electrical/ Electronic Engineering

Mechanical Engineering

Bioengineering

Human Physiology

Medicine

Physics

Biophysics

Job description

GMED North America is seeking a Lead Auditor for medical devices to conduct ISO 13485/MDSAP audits and CE marking activities. This is a home-based role with travel to client sites, reporting to the Unit Manager.

The ideal candidate has hands-on technical experience in active and non-active devices, plastics and metals, with at least four years in R&D, manufacturing, testing or auditing of medical devices and two years in quality management. Remote work is possible.