Senior Quality Engineer Vacant since: 25.06.2026 - Number of jobs: 1 - Location: Zürich (ZH) - Employment type: Permanent - Workload: 100% - Employment start: By agreement
Job Description Thoratec Switzerland GmbH, part of Abbott Laboratories, is a global leader in life‑saving medical technologies. Our innovative systems, developed and manufactured in Zurich, support patients with advanced heart failure. With around 130 colleagues in development, quality, and production, we work together to make a real difference in people’s lives.
Main Responsibilities
Process Validations and Equipment Qualification
– Collaborate with Manufacturing Engineering to validate processes and qualify equipment, evaluate, review, and approve validation and qualification plans, reports, and risk files.
Non‑Conforming Material (NCMR) Handling
– Manage the complete handling of non‑conforming materials, develop and implement corrective and preventive actions, document, track and trend NCMRs, ensure timely corrections, and collaborate with cross‑functional teams.
Root Cause Analysis
– Lead root cause analysis and problem‑solving activities, investigate and resolve non‑conformances, drive CAPA process to identify root causes, implement corrective actions, and verify effectiveness.
Data Analysis and Reporting
– Analyze and report trends and statistical data from investigations in collaboration with Manufacturing Engineering and company management.
Audit Participation
– Participate in internal and external audits, provide documentation and support, act as NCMR SME during audits.
Cross‑Functional Collaboration
– Work closely with cross‑functional teams to address quality‑related issues in engineering, procurement, and manufacturing.
Continuous Improvement
– Champion continuous improvement initiatives within the quality department, implement best practices and innovative solutions to enhance product quality and process efficiency.
Qualifications
Bachelor's degree in engineering, quality management or related field.
Minimum 5 years of experience in quality engineering with focus on NCMR, validations, and CAPA.
Experience in medical devices or similar industry.
Strong knowledge of quality management systems and regulatory requirements.
Excellent problem‑solving skills and root cause analysis experience.
Proficient in quality tools and software.
Strong communication and interpersonal skills; team oriented.
In‑depth experience in process and test method validation (TMV, IMV, IQ/OQ/PQ) and statistical methods.
Fluency in German (written and spoken) and English (written and spoken).
Reporting/Supervisory Structure Reporting line according to the Organizational Chart. Demonstrates ability as an individual contributor, works under management direction, and fulfils tasks based on delegated competencies.
Languages
English
– Orally: Very good knowledge; Written: Very good knowledge.
German
– Orally: Very good knowledge; Written: Very good knowledge.
How to Apply Online form.
Working at Abbott At Abbott, you can work that matters and help people live a healthier life, grow your career, and learn, be your true self. You will have access to career development, an international company, a workplace in a Fortune 500 company, a challenging position in a crisis‑independent industry, a dynamic skilled team, a multinational environment, competitive compensation and benefits, and a workplace in the heart of Zurich.
Abbott Jobs | Apply Now | Abbott Laboratories Careers
#J-18808-Ljbffr
Job Description Thoratec Switzerland GmbH, part of Abbott Laboratories, is a global leader in life‑saving medical technologies. Our innovative systems, developed and manufactured in Zurich, support patients with advanced heart failure. With around 130 colleagues in development, quality, and production, we work together to make a real difference in people’s lives.
Main Responsibilities
Process Validations and Equipment Qualification
– Collaborate with Manufacturing Engineering to validate processes and qualify equipment, evaluate, review, and approve validation and qualification plans, reports, and risk files.
Non‑Conforming Material (NCMR) Handling
– Manage the complete handling of non‑conforming materials, develop and implement corrective and preventive actions, document, track and trend NCMRs, ensure timely corrections, and collaborate with cross‑functional teams.
Root Cause Analysis
– Lead root cause analysis and problem‑solving activities, investigate and resolve non‑conformances, drive CAPA process to identify root causes, implement corrective actions, and verify effectiveness.
Data Analysis and Reporting
– Analyze and report trends and statistical data from investigations in collaboration with Manufacturing Engineering and company management.
Audit Participation
– Participate in internal and external audits, provide documentation and support, act as NCMR SME during audits.
Cross‑Functional Collaboration
– Work closely with cross‑functional teams to address quality‑related issues in engineering, procurement, and manufacturing.
Continuous Improvement
– Champion continuous improvement initiatives within the quality department, implement best practices and innovative solutions to enhance product quality and process efficiency.
Qualifications
Bachelor's degree in engineering, quality management or related field.
Minimum 5 years of experience in quality engineering with focus on NCMR, validations, and CAPA.
Experience in medical devices or similar industry.
Strong knowledge of quality management systems and regulatory requirements.
Excellent problem‑solving skills and root cause analysis experience.
Proficient in quality tools and software.
Strong communication and interpersonal skills; team oriented.
In‑depth experience in process and test method validation (TMV, IMV, IQ/OQ/PQ) and statistical methods.
Fluency in German (written and spoken) and English (written and spoken).
Reporting/Supervisory Structure Reporting line according to the Organizational Chart. Demonstrates ability as an individual contributor, works under management direction, and fulfils tasks based on delegated competencies.
Languages
English
– Orally: Very good knowledge; Written: Very good knowledge.
German
– Orally: Very good knowledge; Written: Very good knowledge.
How to Apply Online form.
Working at Abbott At Abbott, you can work that matters and help people live a healthier life, grow your career, and learn, be your true self. You will have access to career development, an international company, a workplace in a Fortune 500 company, a challenging position in a crisis‑independent industry, a dynamic skilled team, a multinational environment, competitive compensation and benefits, and a workplace in the heart of Zurich.
Abbott Jobs | Apply Now | Abbott Laboratories Careers
#J-18808-Ljbffr
Kontaktdaten:
Thoratec Switzerland GmbH Recruiting-Team
