QA/RA Officer

Job description

ScreenPoint is looking for an enthusiastic and ambitious QA/RA specialist to join the Quality and Regulatory team. The company is ISO 13485 certified and is registering its products for international markets. As a QA/RA specialist you will be working in the Regulatory and Quality team, to ensure compliance with applicable quality and regulatory requirements and standards. You will contribute to the development and improvement of the quality management system and will promote quality procedures within the company.

Qualifications

Knowledge of ISO13485: 2016 and regulations in the field of medical devices; Experience with US FDA CFR820 (QMS) is a plus.

Experience in implementing quality management system or quality improvements, especially with software products.

Experience with product registrations of medical devices within Europe. Other countries is a plus.

Skills in managing and motivating people for achieving high quality.

Keen to progress your career as a QA/RA Officer in an innovative healthcare company

Ability to speak and write in English fluently

Competitive salary applies.

Information

For more information please contact us via jobs@screenpointmed.com.

Application

To apply for this position send a resume and motivation letter to jobs@screenpointmed.com. Applications are processed immediately upon receipt.

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.

The company is located in Nijmegen at Toernooiveld, only a few minutes by bus or train from Nijmegen Centraal Station.

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