Opis stanowiska podany przez pracodawcę:

Duties: 

• Create and maintain quality management system procedures to support regulatory and quality compliance  
• Monitor, analyze, and improve the effectiveness of the quality management system 
• Develop corrective actions, solutions, and improvements 
• Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance  
• Conduct internal audits and ensure timely follow through on resolution of related audit findings  
• Support certification (e.g., ISO 13485), customer and other regulatory audits  
• Participate in the evaluation and approval of  suppliers  
• Provide quality and regulatory related trainings 

Requirements:

• Master’s degree in engineering, scientific, or technical discipline  
• Working knowledge as Quality Engineer (or similar role) having contact with medical device regulatory or other regulated business
• Practical experience with medical device standards such as ISO 13485, ISO 14971, IEC 62304 & IEC 62366  
• General computer and technical literacy and openess for acquiring new knowledge (Considerable knowledge of medical device software and/or hardware development and production – as an advantage)
• Very good interpersonal, written, and verbal communication skills (English B2)  

Offer:

• Work in a fast moving and technologically advanced environment
• Opportunity to gain knowledge in IT & healthcare sector
• An excellent learning environment with prospects for career advancement​
• Referral bonus
• Benefits package
• Employment contract or B2B
• Hybrid model of work 

Permanent job offer. 

Kontakt do pracodawcy:

Kliknij tutaj, aby skontaktować się z pracodawcą lub wysłać swoje CV »