Thoratec Switzerland GmbH, part of Abbott Laboratories' medical device division, is a global leader in implantable and extracorporeal blood pumps based on magnetic levitation technology.
We develop and manufacture life-saving systems in Zurich for advanced heart failure patients requiring short- or long-term circulatory support.
Our team in the heart of Zurich consists of approximately 130 employees working in development, quality, and production of the CentriMag system and HeartMate 3.
Main Responsibilities:
Supplier Quality Assurance:
* Develop and maintain supplier quality assurance processes and procedures.
* Work closely with suppliers to resolve quality issues, implement corrective actions, and provide technical support and guidance on quality-related matters.
* Review and approve supplier quality documentation.
* Monitor and manage Supplier Change Requests in cooperation with a cross-functional team.
Supplier Qualification:
* Evaluate and qualify new suppliers based on their ability to meet quality and performance standards.
* Ensure Supplier Quality Agreements are established.
* Conduct initial assessments and supplier audits to ensure suppliers can deliver high-quality products and materials in accordance with medical device requirements.
Supplier Audits and Assessments:
* Conduct supplier audits and assessments to ensure compliance with quality standards.
Supplier Maintenance:
* Maintain and manage the approved supplier list.
* Conduct regular reviews and re-qualifications of existing suppliers to ensure ongoing compliance with quality standards and current certification.
Supplier Performance Monitoring:
* Continuously monitor and evaluate supplier performance using key performance indicators (KPIs). Identify trends and areas for improvement, and work with suppliers to implement corrective actions and enhance overall performance.
* Lead Continuous Improvement Initiatives. Based on supplier performance drive continuous improvement initiatives in collaboration with the suppliers.
* Prepare and present quality reports and metrics to management.
Cross-Functional Collaboration:
* Work closely with cross-functional teams, including engineering, procurement, and manufacturing, to address quality-related issues and supplier change requests.
Root Cause Analysis:
* Lead root cause analysis and problem-solving activities for supplier-related quality issues.
* Lead the investigation and resolution of supplier-related non-conformances.
* Document and track NCMR`s, ensuring timely and effective corrective actions.
* Drive the CAPA process to identify root causes of quality issues, implement corrective actions, and verify their effectiveness.
* Develop preventive measures to avoid recurrence.
Qualifications:
* Bachelor's degree in engineering, quality management, or a related field.
* Experience in Medical devices or similar industry.
* Excellent problem-solving skills and experience with root cause analysis methodologies.
* Proficient in using quality tools and software.
* Proficiency in both written and spoken German and English.
* Minimum of 5 years of experience in supplier quality engineering or a similar role.
* Strong knowledge of quality assurance principles, methodologies, and tools.
* Experience with supplier audits and assessments.
* Strong communication and interpersonal skills.
* Ability to work independently and as part of a team.
* Certification as ISO 9001 and/or ISO 13485 Auditor (or comparable qualification).
* Certification in quality management (e.g. Six Sigma) is a plus.
Working at Abbott:
* Career development with an international company where you can grow.
* A workplace in a Fortune 500 company and the world's leading manufacturer of medical devices.
* A challenging position in a crisis-independent industry.
* To become part of a dynamic, highly educated, highly skilled, and motivated team.
* Multi-national environment, where we foster the development of our talents within the enterprise.
* Competitive compensations and benefits.
* A workplace in the heart of Zurich.