Quality Assurance Analyst - 14 Month FTC (Medical Devices)

Location: Berlin, Germany

Salary: €48,800–€61,000 gross per year

Company

hirify.global operates in the medical technology sector, delivering regulated medical device products focused on quality, compliance, and patient safety.

What you will do

• Maintain and continuously improve the Quality Management System in accordance with EN ISO 13485 and MDSAP.
• Manage customer complaints, conduct investigations, coordinate with customers and R&D, and implement actions such as batch blocking.
• Perform statistical evaluations of complaints and provide input for risk management workshops.
• Release products after reviewing batch documentation and maintain quality management records.
• Train employees on quality documents and processes, and represent quality topics during audits by notified bodies and regulatory authorities.
• Support product change projects and CAPAs.

Requirements

• University degree in technology or an equivalent qualification, preferably at Bachelor’s level.
• Professional experience in a regulated medical device environment is desirable.
• Knowledge of ISO 13485, MDSAP, MDR, and MDD.
• Fluency in German and English is essential.
• Strong IT skills, attention to detail, resilience, and the ability to work independently.
• Reliability, confidentiality, flexibility, and strong teamwork skills.

Culture & Benefits

• Regulated, quality-driven environment focused on medical device safety and compliance.
• Cross-functional collaboration with R&D, customers, auditors, and regulatory authorities.
• Comprehensive benefits package including pension and insurance.
• Fixed-term employment for 14 months.