Senior Medical Device QA Auditor | Remote & Travel

GMED; Rockville (MD); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Flexible spending accounts

Short-term disability

Long-term disability

Life insurance

401(k)

Telework / flexible working

Paid holidays

Paid parental leave

Job summary

GMED North America is seeking a Medical Device QA Auditor to join our US team. This home-based role with travel to client sites focuses on ISO 13485/MDSAP audits and CE Marking activities to ensure medical devices meet international standards and are go-to-market ready.

The ideal candidate will have hands-on technical experience with medical devices, a strong background in quality management, and the ability to work independently within a regulatory framework.

Qualifications

• Bachelor’s degree in computer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering, human physiology, medicine, physics, or biophysics.
• At least four years of full-time hands-on (R&D, manufacturing, testing and/or auditing) work experience in the field of medical devices or related sectors.
• At least two years in the area of quality management (experience working in an organization governed by regulations and standards).

Responsibilities

• Deliver GMED NA’s third-party audit services to assigned clients in accordance with all GMED, scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs. Analyze quality systems and assess.
• Plan, conduct, and report audits; manage client visits and travel.
• Manage a portfolio of assigned clients based on geographic location and match of qualifications and client contract requirements.
• Participate in professional development and training opportunities to achieve necessary certifications and statuses.

Skills

Quality auditing

Regulatory knowledge

Independent work

Communication skills

English proficiency

Education

Bachelor’s degree in computer or life sciences (as listed)

Tools

ISO 13485 audit tools

Job description

GMED North America is seeking a Medical Device QA Auditor to join our US team. This home-based role with travel to client sites focuses on ISO 13485/MDSAP audits and CE Marking activities to ensure medical devices meet international standards and are go-to-market ready.

The ideal candidate will have hands-on technical experience with medical devices, a strong background in quality management, and the ability to work independently within a regulatory framework.