Career Profile
Quality Assurance Engineer and BSI-certified ISO 13485 Lead Auditor with 8+ years in medical device quality systems and regulatory compliance. Expertise in design controls, Design History File ownership, risk management (ISO 14971), Design Change Assessment, Post-Market Surveillance, and internal audit process ownership. Demonstrated capability in architecting global CAPA programs, leading cross-functional quality initiatives, and achieving regulatory excellence with zero critical audit findings during FDA, TGA, BSI and Notified Body inspections. Based in Munich, Germany.
Experiences
- Owned, reviewed and approved Design History File (DHF) documentation, design inputs/outputs, V&V protocols, and risk management files with full requirements traceability per ISO 13485 and FDA 21 CFR 820.
- Led and authored Periodic Surveillance Reports (PSRs/PSURs) for the Interventional Cardiology portfolio: consolidated complaint, CAPA, field action and clinical data into benefit-risk conclusions, driving updates into risk management and Technical Documentation.
- Performed post-market surveillance signal analysis and trending; escalated signals translating into design/risk file updates, PMCF inputs and CAPA triggers.
- Led impact analysis and risk assessment of EU MDR electronic IFU (eIFU) changes across IC product families: change classification, regulatory evaluation, usability risk assessment, and Technical Documentation alignment.
- Led material change projects (polymer, coating, component substitutions) end-to-end: change strategy, risk assessment, verification test strategy, biocompatibility evaluation and regulatory notification.
- Owned maintenance and sustaining activities for marketed IC products: design changes, component obsolescence, supplier-driven changes, labeling updates and continuous risk file maintenance.
- Executed ISO 14971 risk management: hazard analysis, dFMEA updates, benefit-risk assessments, human factors and usability engineering studies.
- Led root cause investigations for V&V failures, nonconformances and complaints using structured problem solving (8D, Ishikawa, 5 Whys) with statistical rationale for acceptance criteria.
- Led EU MDR compliance implementation across IC products, coordinating Technical Documentation updates and clinical evidence assessments with Regulatory, Clinical and R&D teams.
- Owned the internal audit process as ISO 13485 Lead Auditor: planned quarterly audit schedules across 8+ global sites, conducted audits across quality/compliance/operational functions, and managed follow-up of findings and nonconformities with effectiveness tracking aligned with FDA, TGA, BSI, and Notified Body requirements.
- Architected and deployed a global CAPA program as CAPA Coordinator across 8+ international manufacturing and commercial sites, establishing the first standardized CAPA governance framework harmonized across FDA, EU MDR, TGA and MHRA.
- Designed and delivered CAPA methodology training (8D, RCA, statistical tools) to 1,000+ employees across Manufacturing, Quality, R&D, Regulatory and Clinical teams globally.
- Served as Global CAPA SME during FDA, TGA, BSI and Notified Body inspections: closed all legacy CAPA findings and achieved zero critical observations in all subsequent regulatory reviews.
- Managed 100+ complex CAPAs end-to-end as CAPA Coordinator using 8D, Ishikawa, RCA and statistical methods; executed 100% risk-based effectiveness verification prior to closure in MasterControl eQMS with executive-level KPI reporting.
- Delivered quality KPI dashboards enabling proactive systemic issue identification and data-driven risk decisions across all global sites, providing monthly CAPA metrics and quality trend reporting.
- Planned and executed qualification for 100+ suppliers across mechanical, plastic, electronic and outsourced manufacturing per ISO 13485, FDA 21 CFR 820 and EU MDR.
- Performed 80+ supplier and internal audits per ISO 13485; identified nonconformities and supported effective CAPA implementation.
- Managed NCMRs and Supplier Corrective Action Requests (SCAR) end-to-end; executed supplier process validations (IQ/OQ/PQ) and reviewed First Article Inspection Reports (FAIR) and control plans.
- Led supplier risk assessments for critical and single-source components, supporting supply chain continuity planning.
- Collaborated with R&D and Procurement in Early Supplier Involvement (ESI) for new product programs, advising on design-for-manufacturability and supplier process capabilities.
- Supported supplier selection and technical qualification for NPI programs; led Early Supplier Involvement (ESI) in cross-functional design reviews advising on DFM.
- Reviewed and approved supplier Control Plans, PFMEAs and First Article Inspection Reports (FAIR).
- Collaborated with R&D to develop and validate test methods per applicable standards, strengthening design verification strategies.
- Managed NCMRs and Supplier Corrective Action Requests (SCAR) end-to-end; executed supplier process validations (IQ/OQ/PQ) and reviewed First Article Inspection Reports (FAIR) and control plans.
- Led investigations of internal nonconformities based on root cause investigation techniques.
- Managed global RFQ/RFP processes, supplier evaluation, contract negotiations and SAP-based procurement operations for medical device components and services.
- Developed strategic sourcing strategies identifying cost-reduction opportunities while maintaining quality standards and supply chain continuity.
Certifications
Skills & Proficiency
Core Competencies
- Internal Audit Process Ownership & Lead Auditor (ISO 13485)
- CAPA Coordinator & Program Implementation
- QMS Documentation Management & Records Control
- Design Controls & Design History File (DHF)
- Risk Management (ISO 14971 / dFMEA / Hazard Analysis)
- Post-Market Surveillance (PMS / PMCF / PSR)
- Design Transfer & Sustaining Engineering
- Verification & Validation (V&V / IQ / OQ / PQ)
- Root Cause Analysis (8D / RCA / Ishikawa) & Process Improvement
- Audit & Inspection Readiness (FDA, TGA, BSI, NB)
- Supplier Quality Engineering & Auditing
Regulations & Standards
- EU MDR 2017/745 & Technical Documentation
- FDA 21 CFR 820, ISO 13485, TGA, MHRA
- Standards Adoption (ISO 10555, ISO 80369)
Tools & Systems
- SAP · MasterControl (eQMS) · Windchill · Minitab · Ariba · D365 · Microsoft Office 365
Soft Skills
- Communication with Executive Leadership Team
- Leadership
- Coaching
- Project Management
- Negotiations