Director - Immunoassay Commercial Product Quality (Remote)

Director - Immunoassay Commercial Product Quality Siemens Healthineers 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, providing resources and flexibility to foster your professional and personal growth, while valuing your unique contributions. Responsible for leading the CLS Immunoassay Commercial Product Quality (CPQ) Team. The role focuses on complaint handling, medical device reporting, and field action for Atellica IM, Atellica CI and ADVIA Centaur assays. It develops and executes organizational strategies, processes, goals, and metrics to improve complaint handling, product quality, and customer satisfaction. The role also leads cross‑functional initiatives to enhance the customer experience, reduce quality issues, and ensure regulatory compliance. Responsibilities Serve as a Subject Matter Expert on post‑market topics, processes, and tools. Ensure compliance with applicable regulations and standards. Drive product safety, quality, and customer‑satisfaction decisions with appropriate authority (data‑based and risk‑assessment‑based). Set short‑ and long‑term goals to improve complaint resolution, product reliability, and customer satisfaction. Report medical device reports on time. Address FDA and other regulatory concerns with product recalls, achieving the best outcome. Train and develop group members to complete their duties effectively and pursue career aspirations. Ensure group members possess product and regulatory knowledge to perform duties compliantly. Drive continuous improvement and KPI excellence. Foster a culture of continuous improvement, accountability, and customer focus. Develop and support digitalization strategies for CPQ. Manage IVDR plans and reports for associated product lines. Collaborate cross‑functionally. Qualifications Demonstrated ability to lead and manage people. Direct experience in the in‑vitro diagnostics industry. Strong written, oral, and listening communication skills, with robust problem‑solving ability. Strong knowledge of complaint handling, investigations, medical device reporting, field action, and CAPA processes. Proven experience covering post‑market topics in external inspections (e.g., FDA, TUV). Ability to balance a heavy workload, customer needs, safety, and regulatory compliance. Strong technical knowledge of supported product lines. Experience Typically 8+ years of successful experience in a related field and a proven record of the responsibilities above. Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR. Experience in Quality Systems, MDRs and Field Action preferred. Advanced degree may be substituted for experience, when applicable. Willingness to travel up to 20%. Education BS/BA in a related discipline or an advanced degree; equivalent education and experience acceptable. Who we are We are a team of more than 72,000 highly dedicated Healthineers in over 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients worldwide. How we work When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, and specialists. We value diverse ideas and are united by one purpose: to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably. Base Pay Range Min $172,690 – Max $259,030 Benefits Medical, dental, and vision insurance; 401(k) retirement plan; life insurance; long‑term and short‑term disability; paid parking/public transportation; paid time off, sick leave, 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 race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protection status, veteran or military status, or an unfavorable discharge from military service. Reasonable Accommodations Siemens Healthineers is committed to equal employment opportunity. We will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interview, pre‑employment testing, or otherwise participating in the employee selection process, please fill out the accommodation form provided. Export Control Successful candidates must work with controlled technology in accordance with U.S. export control law. Siemens Healthineers complies fully with the U.S. Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and OFAC sanctions regulations. Data Privacy We care about your data privacy and take compliance with GDPR and other data protection legislation seriously. We ask you not to send your CV or resume by email; instead, create a profile in our talent community to share your CV. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons currently posing as Siemens Healthineers recruiters/employees. 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