Senior quality engineer

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 related field.
• Minimum 5 years of experience in quality engineering with focus on NCMR, validations, and CAPA.
• Experience in medical devices or similar industry.
• Strong knowledge of quality management systems and regulatory requirements.
• Excellent problem-solving skills and experience with root cause analysis methodologies.
• Proficiency in using quality tools and software.
• Strong communication and interpersonal skills, with ability to work effectively in a team environment.
• In-depth experience in process and test method validation (TMV, IMV, IQ/OQ/PQ) and application of statistical methods.
• Experience with CAPA processes.
• Proficiency in written and spoken German and English.

Reporting / Supervisory Structure

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.

Job Details

Job Family: Operations Quality
Division: HF Heart Failure
Location: Technoparkstrass 1, CH 8005, Switzerland
Work Shift: Standard
Travel: No
Medical Surveillance: Not Applicable

Equal Opportunity Statement

Abbott is an equal opportunity employer and welcomes and encourages diversity in its workforce.