Hardikkumar Dineshbhai Dudhat
@hardikkumardineshbha
I maintain medical device quality systems and regulatory compliance under ISO 13485 and EU MDR.
GermanyWhat I'm looking for
At Capreolos GmbH, I maintain and improve the Quality Management System in line with ISO 13485 and EU MDR 2017/745, while fulfilling PRRC responsibilities under Article 15 MDR.
I've supported technical documentation, risk management, CAPA, non-conformance management, change control, internal audits, and management reviews across medical-device environments. Previously at Heraeus Medical Components, I helped maintain regulatory records, prepare submissions, support audit readiness, and improve documentation accuracy with Quality Assurance and Regulatory Affairs teams.
My biomedical engineering background is complemented by manufacturing quality experience at Veena Industries, where I performed inspections, root-cause investigations, corrective actions, supplier-quality activities, and internal audits.
Experience
Work history, roles, and key accomplishments
QM Manager and PRRC
Capreolos GmbH
Sep 2023 - Present (3 years)
Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485 and EU MDR 2017/745 requirements. Support design and development activities through review and maintenance of Technical Documentation and Risk Management files.
Education
Degrees, certifications, and relevant coursework
Anhalt University of Applied Sciences
Master of Science, Biomedical Engineering
2022 - 2023
Master thesis on Innovation Networks in the Biomedical Industry, exploring collaboration models, innovation strategies and industry challenges affecting product development and regulatory readiness.
Anhalt University of Applied Sciences
Master of Science, Biomedical Engineering
2020 - 2023
Master in Biomedical Engineering with focus on Biomedical Systems, Healthcare Technologies, Artificial Intelligence, Innovation Management and Medical Device Development.
BH Gardi College of Engineering and Technology
Bachelor of Engineering, Mechanical Engineering
2017 - 2018
Bachelor project: Designed and developed a low-cost water purification system, applying engineering design principles, validation activities and process optimization concepts.
Gujarat Technological University
Bachelor of Engineering, Mechanical Engineering
2014 - 2018
Bachelor in Mechanical Engineering with focus on Mechanical Design, Manufacturing Processes, Quality Management and Production Engineering.
Availability
Location
GermanyAuthorized to work in
Job categories
Skills
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