Software QMS Specialist

Dentsply Implants, a part of Dentsply Sirona, is looking for an experienced Quality Management System Specialist to support medical software applications for Quality and Regulatory Compliance

Responsibilities:

• Improving Quality Management System processes within quality standards, keep consistency and compliance
• Perform root cause analysis of non-compliance issues, coordination of corrective and preventive actions
• Identify relevant quality-related training needs and deliver trainings
• Provide guidance to the software RnD projects in relation to quality and regulatory topics
• Review and control software products compliance documentation
• Participate in risk management activities
• Participate in quality system audits
• Work closely with international quality team in improving all quality processes

Skills

You have practical experience in software development and/or good understanding of the software development life cycle processes;

You are experienced in technical documentation and procedures reviewing/writing;

You are able to understand and interpret external norms and standards/ experienced to work in regulated industry

You are able to work independently but comfortable working with internal/external stakeholders, an international team across various time-zones

You have excellent communication and negotiation skills

You are proactive, self-motivated, and good at coordinating multiple projects following up with internal/external stakeholders

You have strong analytical and process thinking skills

Experience in Word, Excel, PowerPoint, SharePoint, and other MS office tools required.

Good written and verbal English is a must

You are open for travelling

Will be plus:

Understanding of root cause analysis

Experience in performing internal quality systems audits

Prior participation in risk management activities

Knowledge of FDA QSR, ISO 9001, ISO 13485, ISO 14971, 62304 and similar international standards

Affinity with healthcare domain

Dentsply Sirona Implants offers:

• Challenging job in a multinational environment
• Regular performance evaluation and salary reviews
• Career advice and professional development management
• Medical insurance
• 24 working days paid vacation, 12 paid sick leave
• 3 months paid maternity leave, 3 days paid paternity leave
• Flexible time
• External and internal trainings
• Paid English lessons
• Comfortable office located near Olimpliyska metro station
• Corporate and sport events
• B-day gifts
• Sport activities: swimming pool, gym, table tennis etc.

Our team is waiting for you! Interested? Please send your CV in English.