Medical Devices Regulatory & Quality System Engineer
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Our Company
Technogym inspires 70 million daily users to train using ourinnovative & engaging solutions for fitness, sport and health.
By promoting theHealthness lifestyleof exercise, a balanced diet, and a positive mental approach, AI Tracking & Longevity, Technogym has rapidly grown into a success story of over 2,800 employees at 16 branches, expanding to more than 150 countries.
Your Role
We are looking for aMedical Devices Regulatory & Quality System Engineerto join our HQ Quality Team at Technogym Village (Cesena, Italy).
In this role, you will ensure device conformity and maintain technical documentation.
You will manage post-market surveillance, compliance with ISO standards, and the CA/PA process, while supporting the quality system related to MDR.
Your Impact
Ensure device conformity and maintain technical documentation.
Manage post-market surveillance, vigilance, and reporting obligations.
Ensure compliance with ISO standards (ISO ***** and ISO ****).
Manage and improve the CA/PA process.
Maintain relations with certification bodies.
Support the quality system related to MDR for new product development.
Contribute to continuous improvement of the quality system and develop quality metrics.
Coordinate internal audits and assist in external audits.
About You
Ideally, you are passionate about working out, enthusiastic and proactive, while also down-to-earth and ethical.
What You Should Bring
Master's Degree in Engineering (Electronics, Telecommunications, Biomechanical, Biomedical)
Minimum of 5 years of experience in quality system management for medical devices
Deep knowledge of ISO and ISO ***** standards
Experience with MDR, IMS processes, and procedures management
English proficiency (minimum level B2 CEFR)
Strong problem-solving, organizational, and communication skills
Proficiency in data analysis and statistical aptitude
Technogym is an Equal Opportunities Employer
Technogym is an equal opportunities employer.
We welcome applications from all members of society irrespective of age, sex, sexual orientation, race, religion or belief.
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