Piotr Urbanowicz

A professional quality specialist with many years of experience in the medical devices and other industries. An ISO 13485:2016 and ISO 9001:2015 Lead Auditor with several dozen internal, suppler audits. An expert in quality documentation, supplier quality, continuous improvement and CAPA gaining a thorough knowledge in the expectations required to work in this sector and can apply this to succeed in a new role.

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 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 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

Additional QMS Certifications

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

Academic Degree