Senior QA Engineer – Medical Devices & R&D Quality

Lina Medical; Poznań; Hybrid; PLN 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Private medical care

Sports card

Flexible working time

English lessons

Zusammenfassung

Lina Medical in Poland is seeking a quality/engineering professional to join its R&D team focusing on new medical devices and sustaining existing products.

The role emphasizes leading risk management, usability, and design verification & validation, with hands-on work in metrology and lab environments, collaborating with regulatory officers and suppliers to ensure compliance with ISO 13485, ISO 14971, and MDR requirements.

Qualifikationen

• Minimum 2 years in Quality or Engineering, ideally in Medical Device Industry.
• Master’s degree in engineering (prefer Engineering Management, Quality Management, Biomedical Engineering).
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607, ISO 10993.

Aufgaben

• Participate in R&D projects for new medical devices and maintain existing products.
• Lead risk management, usability, design verification and validation.
• Perform root cause analysis, NC & CAPA processes.
• Prepare quality and technical documentation for design, testing, and regulatory purposes.
• Collaborate with project teams, clinical experts, regulatory officers and suppliers.
• Report to line manager and project manager.

Kenntnisse

QA in medical devices

Risk management

Usability engineering

Design verification & validation

Root cause analysis

CAPA processes

Team collaboration

Prioritization

Ausbildung

Master's degree in engineering

Tools

Quality tools

Jobbeschreibung

Lina Medical in Poland is seeking a quality/engineering professional to join its R&D team focusing on new medical devices and sustaining existing products.

The role emphasizes leading risk management, usability, and design verification & validation, with hands-on work in metrology and lab environments, collaborating with regulatory officers and suppliers to ensure compliance with ISO 13485, ISO 14971, and MDR requirements.