Senior Quality Engineer

Veröffentlicht:
15 April 2025
Pensum:
100%
Vertragsart:
Festanstellung
Arbeitsort:Zurich

Job-Zusammenfassung

Thoratec Switzerland GmbH, Teil von Abbott Laboratories, ist führend in der Medizintechnik. Hier erwartet dich ein innovatives Umfeld mit globalem Einfluss.

Aufgaben

Validierung von Prozessen und Qualifizierung von Geräten für Qualitätssicherung.
Management von nicht konformen Materialien und Entwicklung von Korrekturmaßnahmen.
Durchführung von Ursachenanalysen und kontinuierliche Verbesserung der Prozesse.

Fähigkeiten

Abschluss in Ingenieurwesen oder Qualitätsmanagement, mindestens 5 Jahre Erfahrung.
Ausgezeichnete Problemlösungsfähigkeiten und Erfahrung in der Ursachenanalyse.
Kenntnisse in Qualitätsmanagementsystemen und regulatorischen Anforderungen.

Ist das hilfreich?

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 Senior Quality Engineer to join our team. Main Responsibilities:Process Validations and Equipment Qualification:<ul><li>Collaborate with Manufacturing Engineering to validate processes and qualify equipment.</li><li>Evaluate, review, and approve validation and qualification plans, reports, and risk files.</li></ul>Non-Conforming Material (NCMR) Handling:<ul><li>Manage the complete handling of non-conforming materials (NCMR).</li><li>Train NCMR owners according to the training plan.</li><li>Develop and implement corrective and preventive actions (CAPA) based on NCMR findings.</li><li>Document, track, and trend NCMRs, ensuring timely and effective corrections.</li><li>Collaborate with cross-functional teams to resolve non-conformance issues and prevent recurrence.</li></ul>Root Cause Analysis:<ul><li>Lead root cause analysis and problem-solving activities for quality issues.</li><li>Investigate and resolve non-conformances.</li><li>Drive the CAPA process to identify root causes of quality issues, implement corrective actions, and verify their effectiveness.</li><li>Develop preventive measures to avoid recurrence.</li></ul>Data Analysis and Reporting:<ul><li>Analyse and report trends and statistical data from investigations in collaboration with Manufacturing Engineering and company management.</li></ul>Audit Participation:<ul><li>Participate in internal and external audits, providing necessary documentation and support.</li><li>Act as an NCMR Subject Matter Expert (SME) during audits.</li></ul>Cross-Functional Collaboration:<ul><li>Work closely with cross-functional teams, including engineering, procurement, and manufacturing, to address quality-related issues.</li></ul>Continuous Improvement:<ul><li>Champion continuous improvement initiatives within the quality department.</li><li>Implement best practices and innovative solutions to enhance product quality and process efficiency.</li></ul>Qualifications:<ul><li>Bachelor's degree in engineering, quality management, or a related field.</li><li>Experience in medical devices or a similar industry.</li><li>Minimum of 5 years of experience in quality engineering, with a focus on NCMR, validations, and CAPA.</li><li>Strong knowledge of quality management systems and regulatory requirements.</li><li>Excellent problem-solving skills and experience with root cause analysis methodologies.</li><li>Proficient in using quality tools and software.</li><li>Strong communication and interpersonal skills, with the ability to work effectively in a team environment.</li><li>In-depth experience in process and test method validation (TMV, IMV, IQ/OQ/PQ) and the application of statistical methods.</li><li>Experience with CAPA processes.</li><li>Proficiency in both written and spoken German and English.</li></ul>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: <ul><li>Career development with an international company where you can grow </li><li>A workplace in a fortune 500 company and the world’s leading manufacturer of medical devices </li><li>A challenging position in a crisis independent industry </li><li>To become part of a dynamic, highly educated, highly skilled, and motivated team </li><li>Multi-national environment, where we foster the development of our talents within the enterprise </li><li>Competitive compensations and benefits </li><li>A workplace in the heart of Zurich </li></ul>We are looking for 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! Please follow our Career site and check for available openings: <a href="https://www.jobs.abbott/us/en" target="_blank">Abbott Jobs | Apply Now | Abbott Laboratories Careers</a>

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Thoratec Switzerland GmbH
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Senior Quality Engineer

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Thoratec Switzerland GmbH

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