Praca: Quality Engineer
- 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
- 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)
- 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.