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. 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.
Tasks
- 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.
- Ensure facility-wide compliance with quality systems and regulatory requirements.
- Analyze and report quality metrics and trends; develop, maintain, and present dashboards for quality data reporting and decision-making.
- Resolve or escalate non-conforming product issues and coordinate corrective actions with suppliers; take ownership of supplier non-conformances and manage them throughout the remediation process.
- 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.
- Manage internal and external reporting, reports, and dashboards related to supplier-related KPIs.
- Manage and support change control processes, including assessment, approval, implementation, and effectiveness checks of changes.
- Support the administration and improvement of quality assurance procedures.
- Review and manage supplier change notifications, ensuring timely risk assessment, cross-functional alignment, and proper approval and implementation in compliance with internal procedures and regulatory requirements.
- Actively support the certified bodies and authorities, as well as the internal audits received by the site.
- Analyze trends and determine root causes; implement CAPA actions.
- Travel as required (approximately 20%).
- Perform additional tasks assigned by QA management.
Requirements
- 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 Audit experience preferred.
- Certified body audit and Inspection experience preferred.
- Experience with change management processes and quality systems.
- ISO 9001 and/or ISO 13485 auditor certification preferred.
- Experience performing supplier audits and managing supplier quality activities.
- Strong analytical skills with experience in data reporting and dashboard creation.
- Familiarity with international and domestic medical-device regulatory guidelines.
- Strong communication skills in English (written and spoken).
- German is a strong plus.
- Excellent organizational, time management, and problem-solving skills.
- Initiative, self-responsibility and ownership are requirements for the position.
Benefits
- Meaningful work that directly impacts patients’ lives.
- Career growth opportunities within a global healthcare organization.
- A stable and future-focused industry.
- A collaborative and inclusive team culture.
- A modern workplace in the heart of Zurich.
- An environment where different perspectives and experiences are valued.
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Über uns
Das Team
Our local team of around 140 colleagues across Development, Quality, and Production combines deep expertise with a collaborative, respectful culture, committed to creating an environment where everyone can thrive and grow.