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 the ability as an individual contributor while working under management direction and fulfilling 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 be your true self. You will have access to:
- Career development within an international company where you can thrive.
- A workplace within a Fortune 500 company and the world’s leading manufacturer of medical devices.
- A challenging position in a crisis-independent industry.
- The opportunity to become part of a dynamic, highly educated, skilled, and motivated team.
- A multi-national environment, fostering talent development within the enterprise.
- Competitive compensation and benefits.
- A workplace located in the heart of Zurich.
Apply online using the form below. Only applications matching the job profile will be considered.