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Thoratec Switzerland GmbH is part of the medical device division of Abbott Laboratories, a fortune 500 company with over 115,000 employees worldwide. We are the global market leader for implantable and extracorporeal blood pumps based on magnetic levitation technology. Our life-saving systems, which we develop and manufacture in Zurich, are used for advanced heart failure patients needing short- or long-term circulatory support.
Our location in the heart of the city of Zurich has around 130 employees in the areas of development, quality and production of the CentriMag system and the HeartMate 3.
We are seeking a detail-oriented and experienced Sr Supplier Quality Engineer to join our team.
Main Responsibilities:
Supplier Quality Assurance:
1. Develop and maintain supplier quality assurance processes and procedures.
2. Work closely with suppliers to resolve quality issues, implement corrective actions, and provide technical support and guidance on quality-related matters.
3. Review and approve supplier quality documentation.
4. Monitor and manage Supplier Change Requests in cooperation with a cross-functional team.
5. Evaluate and qualify new suppliers based on their ability to meet quality and performance standards.
6. Ensure Supplier Quality Agreements are established.
7. Conduct initial assessments and supplier audits to ensure suppliers can deliver high-quality products and materials in accordance to medical device requirements.
Supplier Audits and Assessments:
1. Conduct supplier audits and assessments to ensure compliance with quality standards.
2. Maintain and manage the approved supplier list.
3. Conduct regular reviews and re-qualifications of existing suppliers to ensure ongoing compliance with quality standards and current certification.
4. 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.
5. Lead Continuous Improvement Initiatives. Based on supplier performance drive continuous improvement initiatives in collaboration with the suppliers.
6. Prepare and present quality reports and metrics to management.
Cross-Functional Collaboration:
1. Work closely with cross-functional teams, including engineering, procurement, and manufacturing, to address quality-related issues and supplier change requests.
2. Lead root cause analysis and problem-solving activities for supplier-related quality issues.
3. Lead the investigation and resolution of supplier-related non-conformances.
4. Document and track NCMR's, ensuring timely and effective corrective actions.
5. Drive the CAPA process to identify root causes of quality issues, implement corrective actions, and verify their effectiveness.
6. Develop preventive measures to avoid recurrence.
Qualifications:
1. Bachelor's degree in engineering, quality management, or a related field.
2. Experience in medical devices or similar industry.
3. Excellent problem-solving skills and experience with root cause analysis methodologies.
4. Proficient in using quality tools and software.
5. Proficiency in both written and spoken German and English.
6. Minimum of 5 years of experience in supplier quality engineering or a similar role.
7. Strong knowledge of quality assurance principles, methodologies, and tools.
8. Experience with supplier audits and assessments.
9. Strong communication and interpersonal skills.
10. Ability to work independently and as part of a team.
11. Certification as ISO 9001 and/or ISO 13485 Auditor (or comparable qualification).
12. Certification in quality management (e.g. Six Sigma) is a plus.
Working at Abbott:
At Abbott, you can do work that matters and help people to live a healthier and fuller life, grow your career, and learn, be your true self. You will have access to:
1. Career development with an international company where you can grow.
2. A workplace in a fortune 500 company and the world’s leading manufacturer of medical devices.
3. A challenging position in a crisis-independent industry.
4. To become part of a dynamic, highly educated, highly skilled, and motivated team.
5. A multi-national environment, where we foster the development of our talents within the enterprise.
6. Competitive compensations and benefits.
7. A workplace in the heart of Zurich.
We are looking for a highly motivated person who would like to be part of our passionate team with broad responsibilities. Do you have what it takes? Then send us your application including motivation letter, curriculum vitae, letter of recommendation and diplomas today. We are looking forward to meeting you in the heart of Zurich!
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