Quality Assurance Engineer

Great opportunity at EndoStream Medical!

We’re looking for a QA Engineer to join our team, and experience with us the journey of growth and new challenges. Join us and play an active role in supporting and leveraging our production activities.

Key Responsibilities:

Maintain company documentation related to the Quality Management System (QMS).

Monitor subcontractor performance and maintain quality control.

Collaborate with Operations and Quality Control to address issues arising from record reviews, equipment handling and deviations.

Initiate and support NCRs, CAPAs, ECOs, production documentations and other activities within the QMS system.

Conduct training activities based on the annual plan, updated documentation, and refresher training sessions.

Assist in the preparation of internal, external and supplier audits.

Requirements:

B.Sc. degree in Engineering or a related scientific field / CQE certificate

2 years of experience in Quality Assurance within the Medical Device or Pharmaceutical industries, or a related field

Proficiency in English (reading, writing and speaking).

Proficiency in Microsoft Office, Excel and PowerPoint.

Advantage: experience and knowledge with the ISO 13485:2016, EU MDR (Regulation (EU) 2017/745 and FDA regulations (21 CFR Part 820 standards).