Quality Engineer

Abbott seeks a Senior Quality Engineer in Zurich to manage NCMR, CAPA, and validation processes within its Thoratec division, ensuring compliance and driving quality improvements.

This position sits within Thoratec Switzerland GmbH, a key part of Abbott’s global medical technology portfolio focused on advanced heart failure solutions. You will join a multidisciplinary team of approximately 130 professionals in development, quality, and production, playing a central role in maintaining rigorous quality standards and operational excellence.

Responsibilities

• Partner with Manufacturing Engineering to validate processes and qualify equipment.
• Review, evaluate, and approve validation plans, qualification reports, and associated risk documentation.
• Oversee the end-to-end management of non-conforming material reports (NCMR).
• Create and execute corrective and preventive actions (CAPA) derived from NCMR findings.
• Track, document, and analyze NCMR trends to ensure timely resolution.
• Collaborate with cross-functional groups to resolve non-conformances and prevent future issues.
• Lead root cause analysis and problem-solving efforts for quality-related incidents.
• Investigate and close out non-conformance cases.
• Drive the CAPA lifecycle from root cause identification through action implementation and effectiveness verification.
• Design preventive measures to stop recurrence of quality issues.
• Analyze and report statistical data and investigation trends to management and engineering teams.
• Support internal and external audits by providing required documentation.
• Serve as the subject matter expert for NCMR during audit proceedings.
• Work closely with engineering, procurement, and manufacturing to address quality concerns.
• Promote continuous improvement initiatives within the quality department.
• Introduce best practices and innovative solutions to boost product quality and process efficiency.

Requirements

• Bachelor’s degree in engineering, quality management, or a related discipline.
• Prior experience in the medical device sector or a comparable industry.
• At least five years of experience in quality engineering, specifically with NCMR, validations, and CAPA.
• Solid understanding of quality management systems and relevant regulatory standards.
• Strong problem-solving abilities with proficiency in root cause analysis methods.
• Competence in using quality tools and software applications.
• Excellent communication and interpersonal skills, with a proven ability to collaborate in team settings.
• Deep expertise in process and test method validation (TMV, IMV, IQ/OQ/PQ) and statistical methods.
• Hands-on experience managing CAPA processes.
• Fluency in both written and spoken German and English.

What the company offers

• Opportunities for career growth within an international organization.
• The chance to work for a Fortune 500 company and the world’s leading medical device manufacturer.
• A stable role in an industry resilient to economic crises.
• Integration into a dynamic, highly skilled, and motivated team.
• A multinational work environment that supports talent development.
• Competitive compensation and benefits packages.
• A workplace location in the heart of Zurich.

About the company

Abbott fosters a supportive environment where employees can learn, express their true selves, and contribute to helping people live healthier, fuller lives. The company is committed to developing talent within a diverse, multinational setting.

• An environment that encourages learning and authenticity.
• A mission-driven focus on improving patient health and quality of life.
• A multinational culture that values internal talent development.