Atlanta Medical Device QMS Auditor - ISO 13485 Expert

BSI; Atlanta (GA); On-site; USD 98,000 - 124,000; Full time

Benefits offered by this job

Health and dental insurance

Disability insurance

401(k) plan

Life insurance

11 paid holidays

4 weeks paid time off

Job summary

BSI is seeking a QMS Auditor in the Atlanta area to assess ISO 13485, CE Marking and MDSAP schemes. The role involves leading audit teams, preparing reports, and ensuring client understanding and action on findings.

The candidate should have 4+ years in the medical device field, including hands-on design, manufacturing, testing, or clinical evaluation, and be willing to travel extensively. BSI offers competitive compensation and comprehensive benefits.

Qualifications

• Associate's degree or higher in Engineering, Science or related degree required.
• Minimum of 4 years experience in the medical device field including at least 2 years hands-on medical device design, manufacturing, testing or clinical evaluation experience.
• Familiarity with BSI systems and processes during qualification.
• Knowledge of quality management standards and regulatory expectations.
• Excellent verbal and written communication with strong attention to detail.
• Willing to travel on business intensively.
• Public speaking and business development skills are advantageous.

Responsibilities

• Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
• Prepare assessment reports and deliver findings with clear corrective action recommendations.
• Recommend certificate issuance, re-issue, or withdrawal per policy and timelines.
• Maintain account responsibility for nominated accounts and ensure service delivery and growth.
• Lead assessment teams and ensure effective collaboration with clients and team.
• Provide accurate information to support services and keep client records up to date.
• Coach colleagues, especially inexperienced assessors, and assist in onboarding.
• Plan and schedule workloads to maximize revenue-earning activities.

Job description

BSI is seeking a QMS Auditor in the Atlanta area to assess ISO 13485, CE Marking and MDSAP schemes. The role involves leading audit teams, preparing reports, and ensuring client understanding and action on findings.

The candidate should have 4+ years in the medical device field, including hands-on design, manufacturing, testing, or clinical evaluation, and be willing to travel extensively. BSI offers competitive compensation and comprehensive benefits.