Quality Sr Engineer I

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

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

The Senior Quality Engineer supports the design, development, and lifecycle support of medical device software, including software incorporating artificial intelligence, for new and existing products. This role works closely with design and cross-functional teams to support new product introductions, maintain software design documentation, and ensure compliance with applicable quality, regulatory, and industry standards. The position plays a key role in risk management, verification and validation activities, design reviews, cybersecurity considerations, and implementation of software changes throughout the product lifecycle.

How You'll Create Impact

• Partner with design and cross-functional development teams to support quality activities for new productintroductions as well as maintenance on existing product lines.

• Lead or contribute to design, implementation, integration, and maintenance for product developmentprojects.

• Maintain product design documentation and ensure it remains current throughout the product lifecycle. Support product changes, enhancements, defect corrections, and sustaining engineering activities for released products.

• Lead risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.

• Support verification and validation planning, protocol development, execution, and documentation. Participate in design reviews and provide technical guidance to ensure robust, compliant, and maintainable solutions.

• Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.

• Review and approve technical documentation, including, design documents, test protocols, traceability matrices, and change records.

• Provide technical leadership for complex troubleshooting, root cause investigations, and continuous improvement initiatives.

• Mentor engineers and serve as a technical leader across multiple projects and product platforms. Support audit, inspection, and regulatory submission readiness activities as needed.

What Makes You Stand Out

• Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, resource management, product realization and measurement, analysis and improvement processes.

• Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control.

• Demonstrated technical expertise.

• Demonstrates ownership for the integrity of work.

• Able to work independently or as part of a team and consider options for completing work.

• Strong written and verbal communication skills.

Your Background

• Bachelor's Degree in Quality or Engineering field, or an equivalent combination of education and experience.

• Must be familiar with Microsoft Office Suite.

• Must have minimum of 5 years of experience in Quality Engineering field.

• Experience of working in a regulated industry, preferably medical devices.

• Experience working within a quality management system compliant with ISO 13485.

• Strong written and verbal communication skills.

• Proven ability to work effectively across cross-functional teams and influence technical decisions.

Travel Expectations

EOE/M/F/Vet/Disability