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 (NCMR).
Develop and implement corrective and preventive actions (CAPA) based on NCMR findings.
Document, track, and trend NCMRs, ensuring timely and effective corrections.
Collaborate with cross-functional teams to resolve non-conformance issues and prevent recurrence.
Root Cause Analysis:
Lead root cause analysis and problem-solving activities for quality issues.
Investigate and resolve non-conformances.
Drive the CAPA process to identify root causes of quality issues, implement corrective actions, and verify their effectiveness.
Develop preventive measures to avoid recurrence.
Data Analysis and Reporting:
Audit Participation:
Participate in internal and external audits, providing necessary documentation and support.
Act as an NCMR Subject Matter Expert (SME) during audits.
Cross-Functional Collaboration:
Work closely with cross-functional teams, including engineering, procurement, and manufacturing, to address quality-related issues.
Continuous Improvement:
Qualifications:
Bachelor's degree in engineering, quality management, or a related field.
Experience in medical devices or a similar industry.
Minimum of 5 years of experience in quality engineering, with a focus on NCMR, validations, and CAPA.
Strong knowledge of quality management systems and regulatory requirements.
Excellent problem-solving skills and experience with root cause analysis methodologies.
Proficient in using quality tools and software.
Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
In-depth experience in process and test method validation (TMV, IMV, IQ/OQ/PQ) and the application of statistical methods.
Experience with CAPA processes.
Proficiency in both written and spoken German and English.
Reporting/Supervisory Structure:
Reporting line according to the Organizational Chart.
Demonstrates ability as an individual contributor.
Works under management direction.
Fulfills tasks based on delegated competencies given from management.
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:
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
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