Senior Quality Systems Auditor

About the role

We are seeking an experienced QMS Internal Auditor to plan, execute, and report on internal quality system audits in accordance with ISO 13485:2016, 21 CFR Part 820, and FDA IDE requirements.

Responsibilities

• Audit Planning & Execution
• Develop and maintain the annual internal audit schedule based on risk, regulatory requirements, and process criticality.
• Lead and conduct internal audits of all QMS processes, including design controls, production & process controls, CAPA, complaint handling, supplier quality, document/record control, sterilization, and clinical device release.
• Author audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Findings Management & CAPA
• Document nonconformities, observations, and opportunities for improvement with clear objective evidence.
• Assign and track audit findings through closure, including verification of CAPA effectiveness.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• Cook up audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements.
• ISO 13485 Certification & Regulatory Support
• Support third-party certification body (CB) audits and surveillance activities, including readiness assessments, escort duties, hosting audits, and CB interface coordination.
• Aid in the preparation and review of QMS documentation for CB audit submissions.
• Provide gap analysis and remediation support against ISO 13485:2016 and 21 CFR Part 820 / Quality System Regulation (QSR).
• Support IDE compliance activities under 21 CFR Part 812 as needed, including clinical device release audit trail review.
• Audit Program Management
• Maintain the internal audit program, including audit procedure governance, auditor qualification records, and audit metrics reporting to QA leadership.
• Track and trend audit findings to identify systemic quality issues and improvement opportunities.
• Support training of staff on internal audit methods and quality system requirements.
• Travel
• Travel domestically and internationally as required to support multi-site audits, supplier audits, CB audits, or clinical site quality oversight activities (estimated up to 20-30% travel).

Requirements

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline.
• Minimum 10 years of experience in Quality Assurance within the medical device industry.
• Minimum 5 years of direct internal auditing experience against ISO 13485 and/or 21 CFR Part 820.
• Experience with Class III and/or Active Implantable Medical Device (AIMD) development and commercialization strongly preferred.
• Demonstrated experience supporting or participating in third-party CB certification audits (ISO 13485).
• Familiarity with FDA IDE regulations (21 CFR Part 812) and clinical device release processes preferred.
• Thorough working knowledge of ISO 13485:2016 and 21 CFR Part 820 (QSR/QMSR).
• Proficiency with electronic QMS platforms (e.g., Enlil, ZenQMS, MasterControl, Veeva, or equivalent).
• Certifications (Required — At Least One)
• ISO 13485 Lead Auditor certification (e.g., IRCA, Exemplar Global, or equivalent accredited body), ORASQ Certified Quality Auditor (CQA), ORASQ Certified Quality Engineer (CQE) with documented lead auditor training.

Qualifications

• Preferred Qualifications
• Experience auditing sterilization processes (e.g., EO, radiation) and/or sterile medical device manufacturers.
• Exposure to Class III AIMD regulatory submissions (PMA, IDE) or design history file (DHF) review.
• Experience in a startup or scale-up medical device environment building QMS infrastructure.
• Familiarity with supplier quality management and supplier audit execution.
• Experience with ISO 13485 certification pursuit from gap assessment through initial certification.