Quality Engineer - CAPA

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. 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. This role requires strong analytical skills, cross‑functional collaboration, and expertise in quality management systems (QMS). 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. Minimum Qualifications 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. Preferred Qualifications Experience with regulatory audits and inspections. Knowledge of lean manufacturing or Six Sigma methodologies. Ability to manage multiple CAPA projects simultaneously. The base pay range for this position is: $98,140 - $134,937 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company’s plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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. Equal Employment Opportunity Statement Siemens Healthineers is an Equal Opportunity and Aff\. Positive Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Reasonable Accommodations Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. Export Control A successful candidate must be able to work with controlled technology in accordance with US export control law. Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations. #J-18808-Ljbffr Siemens Healthineers