QA Officer

We are looking for a structured and skilled QA Officer who enjoys coordinating to expand our QA/RA team. Our team focuses on improving the quality management system and the registration of ScreenPoint’s products around the world. Will you join our team?

You will work in the QA/RA team with many interactions with our Research, Software Development, Clinical Strategy, Sales and Operations teams. You will be responsible for the implementation and improvement of our quality management system and report to the Head of QA/RA.

Duties and responsibilities

• Maintain the overview of all QMS activities and coordinate the execution of activities.
• Manage internal and external audits and inspections.
  
• Perform the management review and data analysis of the QMS.
• Ensure document control and record control is properly implemented.
  
• Support with handling nonconformities, complaints, and CAPA’s.
• Provide support to the other departments related to QA/RA topics.

About us

ScreenPoint is a leading company that develops and markets breast image analysis and cutting edge machine learning applications and services. Our product Transpara aims at improving breast cancer survival rates by detecting cancers earlier so that treatment can be more effective and less invasive.

• BSc or MSc degree, preferably with a technical or scientific education in Business Administration, Biomedical Technology, or similar.
• Minimum of 5 years experience in a QA/RA position.
• Experience with ISO 13485 and MDSAP.
• Pragmatic and proactive attitude.
• Strong organizational, analysis and communication skills.
• Fluent in English.

Preferred qualifications

• Experience in a QA position for medical devices.
• Experience with coordinating activities within a QMS.
• Experience with an eQMS tool.
  
• Knowledge of medical device regulations (e.g MDR, FDA).
• Knowledge of medical software development (e.g. IEC 62304).