Director - Chemistry Commercial Product Quality (Remote)

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Responsible for leading the CLS Chemistry Commercial Product Quality (CPQ) Team responsible for complaint handling, medical device reporting and Field Action activities for Atellica CH, Atellica CI, ADVIA Chemistry, Dimension and Dimension Vista Assays. This role is responsible for developing and executing organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction. This role leads cross-functional initiatives to enhance the customer experience, reduce quality issues, and ensure compliance with regulatory and internal standards. This role is fully remote, preferably within US East Coast. Responsibilities Serving as a Subject Matter Expert for post market topics, processes and tools. Ensuring compliance with applicable regulations and standards. Drive product safety, product quality, and customer satisfaction related decisions, with appropriate authority (both data-based and risk-assessment-based decisions). Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction. On time reporting of medical device reports. Addressing FDA and other NCA concerns with product recalls to achieve the best outcome (regarding recall classification and where applicable, continued product availability). Training and development of group members to satisfactorily complete their job activities and career aspirations. Ensuring group members have product and regulatory knowledge to perform their jobs compliantly. Driving continuous improvement and excellence in results for Key Performance Indicators (KPIs). Foster a culture of continuous improvement, accountability, and customer focus. Developing and supporting digitalization strategies for CPQ IVDR Plans and Reports for associated product lines Cross functional collaboration This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers Demonstrated ability to lead and manage people. Direct experience in the in-vitro diagnostics industry. Strong communication (written, oral, and listening) and problem-solving skills. Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes. Proven experience covering post market topics in front room external inspections (e.g., FDA, TUV, etc.). Ability to balance heavy workload, customer needs, patient/operator health/safety and regulatory compliance. Strong technical knowledge of supported product lines. Experience: Typically, 8+ years of successful experience in related field and successful demonstration of responsibilities as presented above. Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements. Experience in Quality Systems, MDRs and Field Action recommended. Advanced degree MAY be substituted for experience, where applicable. Willing to travel 20% Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. The base pay range for this position is: $172,690 - $237,446 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time. Equal Employment Opportunity Statement: Siemens Healthineers 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. Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here. Export Control: “A 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.” Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. 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. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. We are a team of 72,000 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. Apply tot his job Apply To this Job