- Manage the CAPA system for the Digital Health Business Line, ensuring CAPAs are completed in accordance with relevant ISO and regulatory requirements (e.g. ISO 13485, CFR 820, EU MDR) in established forums (e.g. CAPA review meetings)
- Support colleagues with CAPA and non-conformance investigations and tasks to determine root cause, corrections, corrective & preventive actions in a high quality and timely manner
- Maintain the internal and supplier audit program, coordinating the execution of audits for various development projects, suppliers and areas of the QMS
- Train, mentor and provide consultation to colleagues in required elements and best practices with respect to CAPA, the CAPA tool and performing audits
- Perform internal and supplier audits as necessary
- Support coordination efforts for external audits (e.g. FDA, MDSAP) and serve as the CAPA and audit subject matter expert (SME) during these audits
- Review, analyze and provide input to relevant monthly metrics
- Maintain and revise applicable QMS processes related to audits and CAPAs as necessary
- Engage in continuous improvement of the CAPA and audit programs by identifying opportunities and recommending actions
- Support additional quality initiatives as needed
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.
- 3 –5 years’ experience working with Medical Devices in Design Projects and successful demonstration of key responsibilities and knowledge related the CAPA and audit management as stated above
- Experience participating in regulatory audits as SME and conducting audits in accordance with regulations and standards. (i.e QSR, MDSAP, EU MDD & MDR, ISO 13485, ISO 9001, IEC 62304, ISO 14971, IEC 62366 etc).
- Strong investigational and problem-solving skills
- Demonstrates a good grasp lean principles that can be applied through successful completion of assignments.
- Strong interpersonal, communication and organizational skills required.
- Must be able to set priorities as well as adapt to changing priorities.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative 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.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.