Senior Quality Engineer

Abbott seeks a Senior Quality Engineer in Zurich to lead NCMR, CAPA, and validation activities for heart failure medical devices within a global life-science team.

This position sits within the Operations Quality job family of the HF Heart Failure division. The successful candidate will join a group of approximately 130 colleagues across development, quality, and production, supporting the manufacturing of innovative systems for patients with advanced heart failure.

Responsibilities

• Partner with Manufacturing Engineering to validate processes and qualify equipment.
• Review, evaluate, and approve validation plans, qualification reports, and risk documentation.
• Oversee the full lifecycle 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.
• Lead root cause analysis and problem-solving efforts for quality deviations.
• Investigate non-conformances and drive the CAPA process to verify corrective action effectiveness.
• Develop preventive measures to stop issue recurrence.
• Analyze statistical data and investigation trends, reporting results to management and engineering teams.
• Support internal and external audits by providing documentation and acting as the NCMR Subject Matter Expert.
• Collaborate with cross-functional groups, including procurement and manufacturing, to resolve quality issues.
• Champion continuous improvement initiatives and implement best practices to boost product quality and process efficiency.

Requirements

• Bachelor’s degree in engineering, quality management, or a related discipline.
• Minimum of five years in quality engineering, specifically focusing on NCMR, validations, and CAPA.
• Experience in the medical device sector or a comparable industry.
• Deep understanding of quality management systems and relevant regulatory standards.
• Strong proficiency in process and test method validation (including TMV, IMV, IQ/OQ/PQ) and statistical methods.
• Proven ability to conduct root cause analysis using established methodologies.
• Fluency in both written and spoken German and English.
• Excellent communication skills and the ability to thrive in a team setting.
• Competence in using standard quality tools and software.

What the company offers

• A role within a Fortune 500 company and the world’s leading manufacturer of medical devices.
• Career development opportunities in an international, multi-national environment.
• Competitive compensation and benefits package.
• A workplace located in the heart of Zurich.
• The chance to join a dynamic, highly skilled, and motivated team.
• Work in a crisis-independent industry making a meaningful impact on patient lives.
• An environment that encourages learning and authenticity.

About the company

Abbott is a global leader in life-saving medical technologies. The company focuses on developing innovative systems to support patients, particularly those with advanced heart failure, while fostering a culture where employees can do meaningful work and be their true selves.

• Employees contribute to work that helps people live healthier, fuller lives.
• The company supports talent development and encourages individuals to learn and express their authentic selves.