Quality Engineer - CAPA

Siemens Healthineers is seeking a dedicated and detail-oriented Quality Engineer to manage and enhance our Corrective and Preventive Action (CAPA) program and processes. The Quality Engineer will be responsible for overseeing the development, implementation, and maintenance of CAPA processes to ensure compliance with regulatory standards and drive continuous improvement in product quality and operational efficiency.

Responsibilities:

• Leading the end-to-end CAPA process, including identification, documentation, investigation, root cause analysis, corrective/preventive action planning, implementation, and effectiveness verification
• Facilitating cross-functional CAPA board meetings, documenting minutes, and following up on action items
• Designing, implementing, and maintaining CAPA processes in alignment with ISO 13485, MDSAP, FDA regulations, and company policies
• Utilizing quality tools (e.g., 5 Whys, Fishbone Diagrams, FMEA) to identify root causes of non-conformances and implement effective solutions
• Ensuring CAPA documentation meets regulatory and audit requirements while maintaining accurate records in the QMS
• Collaborating with engineering, manufacturing, supply chain, and regulatory teams to resolve quality issues and implement CAPA solutions
• Training staff on CAPA processes and promoting a culture of quality and continuous improvement
• Administering the CAPA software tool, including creating and managing user accounts
• Monitoring CAPA metrics, generating reports, and presenting findings to leadership to drive data-driven decisions
• Serving as Subject Matter Expert during internal and external audits, supporting backroom and frontroom activities
• Conducting internal audits for the Molecular Imaging audit program

Requirements:

• Bachelor's degree in engineering, Quality Management, or a related field
• Minimum of 2+ years of experience in quality engineering or a related role
• Proven experience managing CAPA programs in a regulated industry (e.g., medical devices, aerospace, pharmaceuticals, or manufacturing)
• Familiarity with quality management systems (e.g., ISO 13485, 21 CFR Part 820)
• Strong knowledge of CAPA processes, root cause analysis, and quality tools
• Excellent problem-solving and analytical skills
• Proficiency in QMS software (e.g., CATSweb, MasterControl, TrackWise, or similar)
• Strong communication and interpersonal skills for cross-functional collaboration
• Detail-oriented with a focus on compliance and documentation
• Experience with regulatory audits and inspections
• Knowledge of lean manufacturing or Six Sigma methodologies
• Ability to manage multiple CAPA projects simultaneously