Quality Systems Engineer

Do you want to join us in helping to fight the world’smost threatening diseases and enabling access to care for more people aroundthe world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. Foreveryone. Everywhere.

We offer you a flexible and dynamicenvironment with opportunities to go beyond your comfort zone in order to growpersonally and professionally. Sound interesting? Then come and join our globalteam as a Quality Systems Engineer.

Our global team:We are a team of 66,000 highly dedicated employees across more than 70countries passionately pushing the boundaries of what’s possible in healthcareto help improve people’s lives around the world. As a leader in the industry,we aspire to create better outcomes and experiences for patients no matterwhere they live or what health issues they are facing. Our portfolio, spanningfrom in-vitro and in-vivo diagnostics to image-guided therapy and innovativecancer care, is crucial for clinical decision-making and treatment pathways.

Our culture:We are part of an incredible community of scientists, clinicians, developers,researchers, professionals, and skilled specialists pushing the boundaries ofwhat’s possible, to improve people’s lives around the world. We embrace aculture of inclusivity in which the power and potential of every individual canbe unleashed. We spark ideas that lead to positive impact and continuedsuccess. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.

As a QualitySystems Engineer, you will participate in the management, governance, andexecution of Quality Management sub-systems. Specifically, you will be requiredto interact and collaborate with cross-functional teams to promote and driveQuality Systems compliance regarding CAPA, document control, training,internal/external auditing, and supplier quality. You will be expected to applyproblem solving and interpersonal skills and be able to influence and driveresults.

Key Responsibilities

• Facilitate the CAPA program at the Edgewater location,ensuring compliance and monitoring performance.
• Support internal andexternal audit needs regarding the topic of CAPA.
• Support the Document Control, Training, Internal/Externalaudit, and Supplier Quality functions.
• Support other projects/topics, as assigned.

Additional Responsibilities

• Analyze quality trend data to identify and solveproblems.
• Work effectively as anindividual contributor and within a team environment.
• Ensure compliance whilemeeting business objectives.
• Demonstrate and apply abroad knowledge of field of specialization and knowledge of fundamentalconcepts and practices.
• Demonstrate knowledge oforganization's business practices and issues.

RequiredExperience, Skills and Qualification.

•   2-4years of experience in a Quality role within an FDA regulated industrypreferably medical device and diagnostics that includes experience with CAPAand auditing processes.
• ASQcertifications such as CQA, Six Sigma, CQE, CQT or equivalent are highlydesirable.
• Bachelor’s degree in a relateddiscipline or equivalent combination of education and experience. Discipline inEngineering, Biochemistry or Chemistry or other technical field preferred.
• Prefer candidates that possessinternal auditor certification (CQA) from ASQ or equivalent training in IVD /biomedical industry.