QMS Consultant

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

• QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745, ensuring audit readiness, risk-based compliance, and effective stakeholder communication.
• Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
• Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
• Conduct rigorous onsite or virtual stress-testing of core QMS processes:
• Management Responsibility & Resource Management
• Design and Development / Technical Documentation Files
• Production and Service Provision (Cleanroom, Sterilization, Validation)
• CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
• Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
• Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
• Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
• Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
• Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.
• BSI Audit Readiness & Notified Body Interface
• Rigorous Gap Analysis & Nonconformance Classification
• Risk-Based Auditing & Technical File Evaluation
• SME Coaching & Interview PreparationObjective, High-Pressure Stakeholder Communication

Job Summary

• QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745, ensuring audit readiness, risk-based compliance, and effective stakeholder communication.

Roles & Responsibilities

• Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
• Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
• Conduct rigorous onsite or virtual stress-testing of core QMS processes:
• Management Responsibility & Resource Management
• Design and Development / Technical Documentation Files
• Production and Service Provision (Cleanroom, Sterilization, Validation)
• CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
• Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
• Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
• Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
• Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
• Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.
• BSI Audit Readiness & Notified Body Interface
• Rigorous Gap Analysis & Nonconformance Classification
• Risk-Based Auditing & Technical File Evaluation
• SME Coaching & Interview PreparationObjective, High-Pressure Stakeholder Communication

Education & Experience

• 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).
• Proven track record of preparing medical device manufacturers for successful Notified Body audits, specifically with BSI.
• Deep, current knowledge of ISO 13485:2016, ISO 14971 (Risk Management), and European medical device regulations.
• Strong analytical, interviewing, and technical report-writing skills.
• Ability to deliver objective, critical feedback constructively under tight preparation timelines.
• Former BSI Lead Auditor experience is highly preferred.
• Hands-on experience managing a front-room/back-room during a live BSI QMS audit.
• Experience auditing the specific device risk classification and technology relevant to our product portfolio.
• Familiarity with MDSAP requirements.