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GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) and an Auditing Organization Recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States.
GMED North America is hiring a Medical Device QA Auditor with prior industry experience to join our US team. This is a home-based role with travel to client sites.
Utilizing their past experience in engineering, design, or quality control of medical devices, combined with rigorous GMED training, our QA Auditors conduct ISO 13485/MDSAP audits and CE Marking activities for clients to ensure products meet international standards and are go-to-market ready.
The ideal candidate will need hands-on technical experience with medical devices in the following categories: active devices, non-active device, plastics, and metals.
Medical Device Auditor 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:
Manage a portfolio of assigned clients based on geographic location and a match of qualifications and client contract requirements. Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, completing reports, and managing results.
Participate in professional development and training opportunities to achieve necessary certifications and statuses
Required Education/Qualifications
Therapeutic Area of interest
Support Field
Job-specific Competencies:
What We Offer
We offer an excellent benefits package including a group-sponsored health, dental and vision coverage, short-term and long-term disability, 401k plan, company paid life insurance, paid holidays and time off program, Compensatory Time Off providing our employees with great work-life balance.
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture.
Employment Type
Full-time #LI-Remote
Full Time
$118k-144k (estimate)
07/05/2023
07/09/2024
Bethesda, Maryland
25 - 50
Sarina Ascensao