Senior Quality Engineer

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 (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: 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, 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: 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 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 Please follow our Career site and check for available openings: Abbott Jobs | Apply Now | Abbott Laboratories Careers The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: HF Heart Failure LOCATION: Switzerland : Technoparkstrass 1 CH 8005 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter