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.
Numbers & Facts
Location
Austin, TX
Skills
Analysis Skillsunmatched
Auditingunmatched
Biologyunmatched
British Standards Institute (BSI)unmatched
Classification Technologyunmatched
Cleanroomunmatched
Coachingunmatched
Communication Skillsunmatched
Computer Securityunmatched
Consultingunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
File Auditsunmatched
Gap Analysisunmatched
ISO (International Organization for Standardization)unmatched
Insurance Regulationsunmatched
Leadershipunmatched
Medical Equipmentunmatched
Quality Assuranceunmatched
Quality Managementunmatched
Regulationsunmatched
Reporting Skillsunmatched
Resource Managementunmatched
Riskunmatched
Risk Managementunmatched
Sterilizationunmatched
Stress Testingunmatched
Surveillanceunmatched
Technical Writingunmatched
Technical/Engineering Designunmatched
Writing Skillsunmatched
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