Senior Quality Engineer

• Collaborate with Manufacturing Engineering to validate processes and qualify equipment.

• Evaluate, review, and approve validation and qualification plans, reports, and risk files.

• 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.

• 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.

• 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.

• Analyze and report trends and statistical data from investigations in collaboration with Manufacturing Engineering and company management.

• Participate in internal and external audits, providing necessary documentation and support.

• Act as an NCMR Subject Matter Expert (SME) during audits.

• Work closely with cross-functional teams, including engineering, procurement, and manufacturing, to address quality-related issues.

• Champion continuous improvement initiatives within the quality department.

• Implement best practices and innovative solutions to enhance product quality and process efficiency.

• 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.

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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In specific locations, the pay range may vary from the range posted.