Remote Medical Device QA Auditor

ADP, Inc.; Rockville (MD); Remote; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health coverage

Dental coverage

Vision coverage

Flexible spending accounts

Disability insurance

Life insurance

401K retirement

Telework

Flexible working

Paid holidays

Parental leave

Commuter benefits

Internet stipend

Job summary

GMED North America is hiring a Lead Auditor to join our US team for a home-based role with travel to client sites. This exempt, full-time position reports to the Unit Manager in Certification, based in Rockville, MD or Remote.

The role conducts ISO 13485/MDSAP audits and CE Marking activities for medical devices, including active and non-active devices, plastics and metals, ensuring products meet international standards.

Qualifications

• Bachelor’s degree in the fields specified in the job posting.
• Minimum four years of hands-on experience in medical devices or related sectors.
• At least two years in quality management within a regulated environment.
• Ability to function independently and in a team.

Responsibilities

• Deliver GMED NA’s third-party audit services to clients per requirements and regulatory standards.
• Analyze Quality Management Systems per ISO 9001:2015 and ISO13485:2016.
• Assess CE Marking under applicable directives and regulations (MDD/AIMD, EU MDR/IVDR).
• Plan visits, travel, conduct assessments, complete reports, and manage results.
• Participate in professional development to achieve required certifications.

Skills

Quality management

Auditing

Regulatory knowledge

Written communication

Teamwork

Independent work

Organizational skills

Time management

Reliability

Decision making

Critical reasoning

Report writing

Education

Bachelor’s degree in computer/biotech/engineering or related field

Job description

GMED North America is hiring a Lead Auditor to join our US team for a home-based role with travel to client sites. This exempt, full-time position reports to the Unit Manager in Certification, based in Rockville, MD or Remote.

The role conducts ISO 13485/MDSAP audits and CE Marking activities for medical devices, including active and non-active devices, plastics and metals, ensuring products meet international standards.