Senior Medical Device QMS Auditor - ISO 13485

BSI; Raleigh (NC); On-site; USD 98,000 - 124,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Short-term disability

Long-term disability

401k plan

Life insurance

Paid holidays

4 weeks paid time off

Job summary

BSI is seeking a QMS Auditor to analyze quality systems and advance regulatory assessments for medical devices. You will prepare reports, guide clients on corrective actions, and lead assessment teams to ensure top-tier service.

This role requires travel and hands-on experience in design, manufacturing, testing or clinical evaluation. The successful candidate will have an associate degree or higher in engineering or science, strong communication skills, and a demonstrated ability to manage

Qualifications

• Minimum of 4 years experience in the medical device field including at least 2 years hands-on design, manufacturing, testing or clinical evaluation.
• Strong understanding of ISO 13485, CE Marking and MDSAP schemes.
• Excellent verbal and written communication with attention to detail.

Responsibilities

• Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
• Prepare assessment reports and deliver findings to clients with clear corrective actions.
• Lead assessment teams and ensure high-quality service and client relationships.

Skills

Quality systems knowledge

Regulatory affairs

Auditing

Education

Associate's degree or higher in Engineering/Science

Tools

BSI systems

Job description

BSI is seeking a QMS Auditor to analyze quality systems and advance regulatory assessments for medical devices. You will prepare reports, guide clients on corrective actions, and lead assessment teams to ensure top-tier service.

This role requires travel and hands-on experience in design, manufacturing, testing or clinical evaluation. The successful candidate will have an associate degree or higher in engineering or science, strong communication skills, and a demonstrated ability to manage