MojPosao.net – Quality manager (m/f) – Zagreb – USLUGE

The business philosophy of Lentismed is very simple. It is based on the concept of improving life through the development of medical products as a response to the challenges faced by our users. We are dedicated to making tomorrow better than it was yesterday. The right people in our team guarantee our shared success. Therefore, we invite you to join us and help shape the future.

Your tasks and challenges:

• Developing, and monitoring quality management systems (ISO 13485, ISO 9001, ISO 14001, ISO 50001)
• Reporting to the Management Board on the operation of the quality system and the need for improvement
• Communicating with Notified bodies, customers, external consulting professionals, factories, government agencies, and other stakeholders on issues related to the quality management system
• Leading the Medical Device registration process on various EU and Global markets
• Keeping Medical Device Technical File updated with the MDR regulation for the purpose of obtaining CE Mark
• Responsible for declaration labels and content as well as other documentation needed for new products
• Ensuring compliance with the regulations and quality standards
• Responsible for and carries out internal auditing processes and the coordination and preparation for external audits.

Your desirable experiences and skills:

• At least 3 years of experience in quality management/assurance roles, preferably in the Medical device industry
• University degree
• Highly experienced and proficient in quality standards (ISO 9001 standard)
• Knowledge of ISO13485 is an advantage
• Knowledge of Medical Device Regulation is a huge plus
• Holds an auditor's certificate
• High level of computer literacy (MS Office)
• Proficiency in English
• Willingness to occasionally travel within and outside of the EU

Your character is important to us:

• You always find a way and go a step further
• You feel that the pressure of privilege
• You want to succeed, not just participate
• Trust is essential to you
• You respect others, but you also keep to yourself
• You receive well and openly give constructive criticism
• You're not afraid to make mistakes because you learn from mistakes
• Every day, you try to outperform yourself from yesterday

What do you get with us?

• Competitive salary
• “All for one, one for all” working atmosphere
• Working in an international environment
• Opportunity to advance in a fast-growing company and learn about medical device industry

Please forward your CV and letter of motivation in English language via application link. Only successful candidates will be notified.