Senior Quality Engineer

Senior Quality Engineer

Zurich, Switzerland | Thoratec Switzerland GmbH (Abbott)

Build life‑saving technology — in a team where your growth matters.

At Thoratec Switzerland GmbH, part of Abbott’s Medical Devices division, we develop and manufacture advanced heart pump systems that support patients with severe heart failure around the world. Our technologies — including CentriMag and HeartMate 3 — are designed and produced in Zurich and play a vital role in saving and improving lives every day.

Our local team of around 140 colleagues across Development, Quality, and Production combines deep expertise with a collaborative, respectful culture. We believe that the best innovations happen when diverse perspectives come together — and we are committed to creating an environment where everyone can thrive and grow.

As we continue to expand, we are looking for a Senior Quality Engineer to join our team and help ensure the highest standards of quality, safety, and performance for our products.

About the Role

In this role, you will contribute to the quality and compliance of life‑saving medical devices while working closely with cross-functional teams. You will play an important part in strengthening quality systems, driving improvements, and supporting both internal and external stakeholders.

This is a role for someone who enjoys collaboration, problem-solving, and continuous learning — and who wants to make a meaningful impact through their work.

What You’ll Do

• Implement aspects of production quality assurance and document control activities to ensure compliance with internal procedures and international regulations.
• Execute quality organization activities ensuring product quality, performance, and safety.
• Support communication with Operations and external suppliers to resolve quality issues.
• Drive Quality Systems goals and objectives at site level.

Duties and Responsibilities:

Compliance:

• Ensure facility-wide compliance with quality systems and regulatory requirements.

Quality Analysis and Reporting:

• Analyze and report quality metrics and trends.
• Develop, maintain, and present dashboards for quality data reporting and decision-making.

Non-conforming Product:

• Resolve or escalate issues and coordinate corrective actions with suppliers.
• Take ownership of supplier non-conformances and manage them throughout all the remediation process

Supplier Quality:

• Perform audits at supplier sites to ensure compliance with quality and regulatory requirements.

Manage supplier qualification documentation, ensuring completeness and compliance.

• Coordinate and oversee validations conducted at supplier locations.
• Manages internal and external reporting, reports, and dashboards related to supplier-related KPIs

Change Management:

• Manage and support change control processes, including assessment, approval, implementation, and effectiveness checks of changes.

Quality System Procedures:

• Support the administration and improvement of quality assurance procedures.

Supplier Change Notifications:

• Reviews and manages supplier change notifications, ensuring timely risk assessment, cross-functional alignment, and proper approval and implementation in compliance with internal procedures and regulatory requirements.

Audit

• Actively support the certified bodies and authorities, as well as the internal audits received by the site.

Corrective and Preventive Actions:

• Analyze trends and determine root causes.
• Implement CAPA actions.

General:

• Travel as required (20% aprox.)
• Perform additional tasks assigned by QA management.

Qualifications:

• Bachelor or Master degree in Science, Engineering, or other technical field.
• Minimum 5 years of experience in a medical-device manufacturing or other regulated industry in a quality-related role.
• Experience conducting and / or reviewing validations.
• Supplier Au