Quality Management Engineer

As German company for medical devices, ranking among the top companies in its field, we want to expand our Quality Management department to support our international sales structure with offices in Germany, Turkey and Serbia and their worldwide customers. Therefor we are looking for a new team member for the position of Quality Management Engineer in our facilities in Niš, Serbia.

If you are passionate on development and production involving different materials and techniques and if you dispose of a structured work method, you are very welcome.

As a Quality Management Engineer you support our quality management system with your administrative skills. You will work in integrated teams together with engineers and developers and your target is to prepare all processes and documents. Documentation needed for each phase will be aligned between Quality Management, Production and developers, applying knowledge of engineering and manufacturing processes.

Constant improvement, integrated testing and proactive elimination of errors are a matter of course in our hardware, electronic and software development teams.

Responsibilities of the Quality Management Engineer in the Quality Management department:

• Review, analyze and statistic reports of test protocols from production orders, applying knowledge of engineering and manufacturing processes
• Create and amend test protocols according latest requirements
• Review and submit technical-documentation files for CE marked products to management for approval, and transmit approved documents to notified body
• Create technical-documentation files for product CE marking according legal requirements, applying knowledge of standards and regulations
• Prepare and support documentation for FDA 510(k) premarket notification submissions, ensuring compliance with relevant regulatory requirements
• Communicate with all related external partners like trainers, consultants, notified body and authorities relevant in quality management
• Develop and maintain processes and documentations in compliance with ISO 13485, ISO 9001, MDR 201/745 and FDA 21 CFR Part 820 
• Monitor status of projects to ensure documentation is submitted according to schedule
• Serve as an interface between development, quality management and production
• Conduct internal and external audits according standards ISO 13485, ISO 9001, MDR 2017/745 and FDA 21 CFR Part 820
• Take over special roles such as, ESD Coordinator, Safety Officer and QMS Trainer
• Reference: Zm2zEH141e2HIti8b3v2Q4gaOnxJU7cEADP4-vNKPQ0.

Required Skills/Qualification:

• Good experience from other production organizations
• Engineering degree in technical field or quality management
• At least 2-3 years of work experience in the technical field of mechanic, electronic, software or quality management
• Good knowledge of Microsoft Office (Excel, Word, Power point, Outlook)
• Comprehensive knowledge of standards and regulations, including ISO 9001, ISO 13485, MDR 2017/745 and FDA 21 CFR Part 820, as well as experience with 510(k) submissions
• Independent working and problem-solving and responsible attitude,  eager to learn and improve
• Good team player and communicator, also able to work independently
• Fluency in English

Have we sparked your interest? Then send us your full application, in English language, with info about your earliest possible entry date. Please indicate your salary expectation in your motivation letter.