QMS Audit Readiness Lead for Medical Devices

Katalyst CRO; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a QMS Consultant to plan, scope, and lead mock audits ensuring readiness for a BSI notified body audit. You will evaluate the QMS against ISO 13485:2016 and EU MDR 2017/745, ensuring risk-based compliance and effective stakeholder communication.

Role requires in-depth knowledge of medical device QMS, effective reporting, and strong cooperation with leadership to address gaps before a live audit.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 8 years of experience in the Medical Device industry, specifically in Quality Assurance or Regulatory Affairs.
• Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).

Responsibilities

• Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
• Evaluate QMS against ISO 13485:2016 and EU MDR 2017/745.
• Conduct onsite or virtual stress-testing of core QMS processes (Management Responsibility & Resource Management, Design and Development/Technical Documentation Files, Production and Service Provision, CAPA, Complaint Handling, PMS).
• Review Technical Files and DHF to ensure alignment with BSI expectations.
• Prepare mock audit reports with Major and Minor nonconformances using Notified Body criteria.
• Provide gap analysis outlining vulnerabilities and remediation strategies.
• Debrief leadership and process owners with actionable guidance for interfacing with BSI auditors.
• Assess SME readiness through front-room/back-room interview dynamics.
• BSI Audit Readiness & Notified Body Interface; Nonconformance Classification; Risk-Based Auditing; Technical File Evaluation.
• SME coaching and interview preparation with objective, high-pressure stakeholder communication.

Skills

Analytical skills

Interviewing

Technical report-writing

QMS auditing

Education

Bachelor's degree in Engineering, Life Sciences, or related

ISO 13485 Lead Auditor certification

Job description

Katalyst CRO is seeking a QMS Consultant to plan, scope, and lead mock audits ensuring readiness for a BSI notified body audit. You will evaluate the QMS against ISO 13485:2016 and EU MDR 2017/745, ensuring risk-based compliance and effective stakeholder communication.

Role requires in-depth knowledge of medical device QMS, effective reporting, and strong cooperation with leadership to address gaps before a live audit.