Quality Systems Engineer
Siemens Healthcare Diagnostics Inc.

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Quality Systems Engineer.

Our global team : We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to 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 matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer 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 of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers .

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

Key Responsibilities

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

Additional Responsibilities

• Analyze quality trend data to identify and solve problems.
• Work effectively as an individual contributor and within a team environment.
• Ensure compliance while meeting business objectives.
• Demonstrate and apply a broad knowledge of field of specialization and knowledge of fundamental concepts and practices.
• Demonstrate knowledge of organization's business practices and issues.

Required Experience, Skills and Qualification.

• 2-4 years of experience in a Quality role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes.
• ASQ certifications such as CQA, Six Sigma, CQE, CQT or equivalent are highly desirable.
• Bachelor's degree in a related discipline or equivalent combination of education and experience. Discipline in Engineering, Biochemistry or Chemistry or other technical field preferred.
• Prefer candidates that possess internal auditor certification (CQA) from ASQ or equivalent training in IVD / biomedical industry.

The pay range for this position is $67,160 - $92,345 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is 5% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be fou nd here: https://benefitsatshs.com/index.html

This information is provided per the required state Equal Pay Act. B ase pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

"Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is 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."

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers .

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about .

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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.

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