Senior Quality Engineer, Medical Device Software

Zimmer Biomet; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Job summary

Zimmer Biomet is seeking a Senior Quality Engineer to lead software quality activities across the product lifecycle. You will partner with design and cross-functional teams to ensure robust, compliant software for medical devices and AI-enabled features.

The role requires at least 5 years in Quality Engineering, familiarity with ISO 13485, and strong risk management, verification, and validation capabilities.

Qualifications

• Bachelor's degree in Quality or Engineering or an equivalent combination of education and experience.
• Minimum 5 years of experience in Quality Engineering.
• Experience in a regulated industry, preferably medical devices.
• Experience with ISO 13485 quality management systems.
• Strong written and verbal communication skills.

Responsibilities

• Support design, development, and lifecycle activities for medical device software.
• Lead or contribute to design, implementation, integration, and maintenance for product development projects.
• Maintain product design documentation and oversee changes throughout the lifecycle.
• Lead risk management activities, including hazard analysis and risk controls.
• Support verification and validation planning, protocols, and documentation.
• Collaborate with quality, regulatory, systems, and test engineering teams.
• Review and approve technical documents, test protocols, and change records.
• Provide technical leadership for complex troubleshooting and root cause investigations.
• Mentor engineers and support audit readiness and regulatory submissions.

Skills

Quality system

QA techniques

Technical leadership

Ownership of work

Independent work

Communication skills

Cross-functional collaboration

Education

Bachelor's in Quality/Engineering

Tools

Microsoft Office

Job description

Zimmer Biomet is seeking a Senior Quality Engineer to lead software quality activities across the product lifecycle. You will partner with design and cross-functional teams to ensure robust, compliant software for medical devices and AI-enabled features.

The role requires at least 5 years in Quality Engineering, familiarity with ISO 13485, and strong risk management, verification, and validation capabilities.