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 As Quality Support Operator to focus Quality Support 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. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Support Operator you will be responsible for: Facilitating the timely completion of FCA Effectiveness Check via phone, email, faxback and/or fedex confirmation. Maintaining FCA Weekly Status Report Monitoring and respond to Siemens Healthineers US CC TS FCA EC FAX shared mailbox. Handling replacement of reagents when required as part of FCA. Creating MS Notification for additional Customer requests. Check Reconciliation Report. Working closely with Product Support Teams/Business Units and Data Management Teams to ensure install base accuracy and data integrity for FCA Compliance Reporting Organizing, preparing mails and tracking FDA Regulated Customer Safety Advisory Notices for all patient safety recalls. o Ensures proper customer signatures are obtained via electronic tracking and reporting. o Identifies and executes project’s implementation strategy in accordance with Industry Regulations for timely communication of patient safety recalls. Participating in unannounced FDA Audits for previously executed projects relating to Field Corrective Actions. Creating and Sending Customer Refusal Letters for Diagnostics and Imaging Mandatory Updates. Monitoring completion form mailbox and process completion forms for dealers. Providing reports on progress and actions on a regular basis by researching, documenting, and presenting findings. Creating Tam Summary and order Dell Update kits for LCM to ACM Migration Project This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers Managing multiple field corrective action/projects at any given time. Participating in unannounced FDA Audits for previously executed projects relating to Field Corrective Actions. Maintaining professional and courteous communication with internal and external customers to ensure smooth, clear, concise, and timely communication of all types. Required skills to have for the success of this role Bachelor’s degree or equivalent experience required Knowledge of SAP a plus but not required You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook) Strong communication skills needed, both verbal and written Willing to travel up to 5% JOB LOCATION: CARY, NC 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. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site. 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. #LI-EZ1 Organization: Siemens Healthineers Company: Siemens Medical Solutions USA, Inc. Experience Level: Experienced Professional Full / Part time: 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.