Nick Ngankep
@nickngankep
Experienced Quality Manager in regulated healthcare and medical devices.
FranceWhat I'm looking for
I am a Quality and QHSE manager with over 5 years' experience in regulated industries such as healthcare and medical devices. I led the overhaul of quality and safety systems across four sites, coached QHSE teams, and supported CSR transformation and cross-functional projects.
I maintain and improve Quality Management Systems and regulatory compliance (ISO 13485, EU MDR 2017/745, GMP), author technical documentation, perform audits and IQ/OQ/PQ validations, and drive non-conformity/CAPA processes using tools like FMEA, 5 Whys and 8D to deliver measurable safety and quality improvements.
Experience
Work history, roles, and key accomplishments
LFLed the overhaul of quality and safety systems across 4 sites to align with ISO 13485, EU MDR 2017/745 and RABC, strengthening non-conformity management and supplier audit processes.
ESQuality System Specialist
Essity
Jan 2021 - Jan 2024 (3 years)
Maintained the QMS and ensured regulatory compliance for medical devices (ISO 13485, MDR), authored technical documentation and led audits and IQ/OQ/PQ validations to support continuous improvement.
SPImproved training processes and CAPA management, defined and monitored quality indicators, and applied anomaly management methodology to strengthen QA systems.
Quality Management Coordinator
Cermix France
Jan 2018 - Jan 2020 (2 years)
Prepared and conducted internal and external audits, led management reviews and corrective action tracking, and developed QHSE training modules to improve compliance.
Education
Degrees, certifications, and relevant coursework
EPENSAM Paris
Master's Degree, Quality, Health, Safety and Environment (QHSE)
2020 - 2021
Master’s degree in Quality, Health, Safety and Environment (QHSE) from ENSAM Paris completed from 2020 to 2021.
IHINSA Hauts-de-France
2018 - 2020
Attended INSA Hauts-de-France from 2018 to 2020.
Tech stack
Software and tools used professionally
Availability
Location
FranceAuthorized to work in
Job categories
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