Quality Engineer - CAPA

About the role

Siemens Healthineers is seeking a dedicated and detail-oriented Quality Engineer to manage and enhance our Corrective and Preventive Action (CAPA) program and processes.

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.
• Advanced degree or certifications (e.g., ASQ CQE, Six Sigma) preferred.
• 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.

Qualifications

• Experience with regulatory audits and inspections.
• Knowledge of lean manufacturing or Six Sigma methodologies.
• Ability to manage multiple CAPA projects simultaneously.

Skills

• Strong analytical skills.
• Expertise in quality management systems (QMS).
• Strong knowledge of CAPA processes, root cause analysis, and quality tools.
• 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.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term and short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time