Quality Assurance Engineer

We're Hiring

Great opportunity at EndoStream Medical! We’re looking for a QA Engineer to join our team. This might be your chance to join our Quality Assurance team and support 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 documentation 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 /a related scientific field or 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).