we are looking for a QA Engineer.
Job Requirements & Responsibilities
Support and manage core quality activities, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Complaints, and Change Control (ECO).
Assist in the performance and preparation of both internal and external quality audits.
Coordinate and follow up on employee training, qualification, and competency activities to ensure organizational compliance.
Support the qualification and ongoing evaluation of suppliers.
Support the production activities (Review Device History Records (DHRs) and quality documentation for completeness and batch release).
Participation in Design Reviews and verification of execution of Action Items related to quality issues.
Provide quality support for V&V processes, including software validation, equipment validation, and the review of engineering documents.
Administer controlled documents and maintain quality records.
Requirements: Bachelors degree in science or mechanical / (bio-)medical engineering.
At least 3 years experience in quality assurance in medical device.
Experience with medical devices that integrate both Hardware and Software
Strong familiarity with ISO standards and regulatory requirements (e.g., ISO 13485 or 21 CFR 820).
Good communication and teamwork skills.
Good technical understanding.
Proficient in English (reading, writing, speaking)
This position is open to all candidates.