Quality Engineer

pbThoratec Switzerland GmbH /b, part of bAbbott Laboratories, /b 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. /ppbMain Responsibilities: /b /ppbProcess Validations and Equipment Qualification: /b /plipCollaborate with Manufacturing Engineering to validate processes and qualify equipment. /p /lilipEvaluate, review, and approve validation and qualification plans, reports, and risk files. /p /lipbNon-Conforming Material (NCMR) Handling: /b /plipManage the complete handling of non-conforming materials (NCMR). /p /lilipDevelop and implement corrective and preventive actions (CAPA) based on NCMR findings. /p /lilipDocument, track, and trend NCMRs, ensuring timely and effective corrections. /p /lilipCollaborate with cross-functional teams to resolve non-conformance issues and prevent recurrence. /p /lipbRoot Cause Analysis: /b /plipLead root cause analysis and problem-solving activities for quality issues. /p /lilipInvestigate and resolve non-conformances. /p /lilipDrive the CAPA process to identify root causes of quality issues, implement corrective actions, and verify their effectiveness. /p /lilipDevelop preventive measures to avoid recurrence. /p /lipbData Analysis and Reporting: /b /plipAnalyze and report trends and statistical data from investigations in collaboration with Manufacturing Engineering and company management. /p /lipbAudit Participation: /b /plipParticipate in internal and external audits, providing necessary documentation and support. /p /lilipAct as an NCMR Subject Matter Expert (SME) during audits. /p /lipbCross-Functional Collaboration: /b /plipWork closely with cross-functional teams, including engineering, procurement, and manufacturing, to address quality-related issues. /p /lipbContinuous Improvement: /b /plipChampion continuous improvement initiatives within the quality department. /p /lilipImplement best practices and innovative solutions to enhance product quality and process efficiency. /p /lipbQualifications: /b /plipBachelor's degree in engineering, quality management, or a related field. /p /lilipExperience in medical devices or a similar industry. /p /lilipMinimum of 5 years of experience in quality engineering, with a focus on NCMR, validations, and CAPA. /p /lilipStrong knowledge of quality management systems and regulatory requirements. /p /lilipExcellent problem-solving skills and experience with root cause analysis methodologies. /p /lilipProficient in using quality tools and software. /p /lilipStrong communication and interpersonal skills, with the ability to work effectively in a team environment. /p /lilipIn-depth experience in process and test method validation (TMV, IMV, IQ/OQ/PQ) and the application of statistical methods. /p /lilipExperience with CAPA processes. /p /lilipProficiency in both written and spoken German and English. /p /lipbReporting/Supervisory Structure: /b /plipReporting line according to the Organizational Chart. /p /lilipDemonstrates ability as an individual contributor. /p /lilipWorks under management direction. /p /lilipFulfills tasks based on delegated competencies given from management. /p /lipbWorking at Abbott /b /ppAt 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: /plipCareer development with an international company where you can grow /p /lilipA workplace in a fortune 500 company and the world’s leading manufacturer of medical devices /p /lilipA challenging position in a crisis independent industry /p /lilipTo become part of a dynamic, highly educated, highly skilled, and motivated team /p /lilipMulti-national environment, where we foster the development of our talents within the enterprise /p /lilipCompetitive compensations and benefits /p /lilipA workplace in the heart of Zurich /p /lipPlease follow our Career site and check for available openings: /p