Sr Quality Systems Specialist Now’s our time to inspire the future of healthcare together. Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us. The Sr. Quality Systems Specialist will participate in the management, governance, and execution of Quality Management Sub-Systems. Specifically, the Sr. Quality Systems Specialist will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems Compliance regarding training and documentation control (specifically Design History Files and SOPs). Additionally, this role will support specific quality improvement projects as required for QT and other business initiatives. The Sr. Quality Systems Specialist is expected to apply problem solving and interpersonal skills and be able to influence and drive results. Primary Job Responsibilities Manage the daily POC Document Control Workflow within the Edgewater location. Support the External Audit processes by participating as an SME for the Quality Document Process. Support the monitoring and reporting of Quality Systems key performance indicators (KPIs). Manage the daily Learn4U Training Workflow. Assist with development and presentation of the POC new hire onboarding training program. Assist with development and presentation of the POC ISO 13485 training program. Additional Responsibilities: Analyze complex quality trend data to identify and solve problems. Design and develop systems for recording, evaluating, and reporting quality data. Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Conduct complex audits and/or surveys to determine acceptability of quality controls. Knowledge/Skills, Education, and Experience AS degree in a related discipline or 5+ years of equivalent combination of education and experience. Prefer disciplines in English, technical writing, Science or similar. Prefer candidates that possess ASQ or equivalent training in IVD/biomedical industry 5+ years of experience in a Quality role within an FDA regulated industry preferably medical device and diagnostics that includes experience with document control, training, and auditing processes ASQ certifications such as CQA, Six Sigma, CQE, CQT or equivalent preferred Knowledge of Quality Document Control as it relates to ISO 13485 required Knowledge of SAP PLM experience required 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. 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. As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law. (Note: Accommodations may be requested for certain medical or religious reasons) #LI-EM1 Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics 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. 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