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. 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.

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.

• 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.