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.
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 elevate 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% approx.)
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 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.
Why Join Abbott / Thoratec?
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
#J-18808-Ljbffr
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.
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 elevate 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% approx.)
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 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.
Why Join Abbott / Thoratec?
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
#J-18808-Ljbffr
Ingénieur Qualité Senior Arbeitgeber: jobup
Als Arbeitgeber bietet unser Unternehmen ein dynamisches und unterstützendes Arbeitsumfeld, das auf Teamarbeit und kontinuierliche Weiterbildung setzt. Wir fördern die berufliche Entwicklung unserer Mitarbeiter durch gezielte Schulungen und Aufstiegsmöglichkeiten, während wir gleichzeitig attraktive Vergütungs- und Sozialleistungen bieten. Unsere Lage in der Schweiz ermöglicht es Ihnen, in einem internationalen Umfeld zu arbeiten und von einer hohen Lebensqualität zu profitieren.
