Piotr Urbanowicz

I am an accomplished Quality Assurance and Supplier Quality Specialist with extensive experience across the medical devices, SaMD, IVD, and regulated healthcare industries. My background spans quality engineering, supplier management, internal/external auditing, QMS ownership, CAPA leadership, and regulatory compliance under standards including ISO 13485, ISO 9001, IEC 62304, MDSAP, MDR, and FDA 21 CFR 820.

Lead Auditor Qualifications (BSI)

ISO 13485:2016 Lead Auditor

ISO 9001:2015 Lead Auditor These certifications position you as a highly credible auditor capable of leading internal, supplier, and external audits across regulated environments.

Medical Device & SaMD Regulatory Training (TÜV Nord)

IEC 62304 – Software Lifecycle Validation

IEC 62366‑1 – Usability Engineering

ISO 14971 – Risk Management for Medical Devices

EU MDR 2017/745 Requirements

Regulatory Affairs for Medical Devices This cluster of training demonstrates deep competence in medical device regulations, risk management, and SaMD compliance—highly valuable for QA, RA, and QMS roles.

Quality & Process Improvement

Six Sigma Green Belt Strengthens your capability in root cause analysis, CAPA effectiveness, and continuous improvement initiatives.

Additional QMS Certifications

Manager & Internal Auditor for ISO 13485

Manager & Internal Auditor for ISO 14001 These reinforce your ability to manage, maintain, and improve integrated management systems.

Academic Degree

BSc in Biotechnology, University of Silesia Provides the scientific foundation for working in medical devices, IVD, and healthcare‑related industries.