QA/RA Engineer

Develop, implement, and maintain quality management systems (QMS) in compliance with ISO 13485.
Conduct internal audits and support external audits to ensure compliance with MDD/MDR, and FDA regulations.
Manage CAPA processes, non-conformance investigations, and document control.
Oversee supplier quality assurance and ensure adherence to quality standards for Class IIa medical devices.
Regulatory Affairs (RA):

Prepare and maintain technical documentation to meet EU MDR (Medical Device Regulation) and MDD requirements.
Assist with global regulatory submissions, including FDA (21 CFR Part 820) and other applicable regulations.
Monitor regulatory changes and ensure ongoing compliance with current standards.

We are seeking a proactive and detail-oriented QA/RA Engineer to join our dynamic team in the medical device sector. You will play a pivotal role in ensuring the quality and regulatory compliance of our Class IIa medical devices, contributing to the company’s commitment to delivering safe and effective products.

Degree in engineering, life sciences, or related field.
Proven experience in QA for medical devices, with exposure to Class IIa devices.
Working knowledge of MDD and MDR regulations; familiarity with FDA requirements is highly desirable.
Hands-on experience with ISO 13485 quality management systems.
Strong problem-solving and analytical skills with attention to detail.
Excellent communication and team collaboration abilities