Sr. Director, Quality Operations Position Overview Maintain and oversee the Quality System for the Point of Care (POC) Business. This includes responsibility as the Management Representative for the Edgewater site, coordination with Supply Chain Management (SCM) on product quality related initiatives, operation of the document control and design quality engineering functions, oversight of CAPA and training processes, and overall audit readiness. Drive quality Key Performance Indicators (KPI) metrics and report results to management. Assist in key quality initiatives to improve product quality through use of the Healthineers Performance System (HPS) practices. Establish process metric goals in partnership with site Quality leads. Aid site Quality heads and share best practices across POC. Liaison with Authorities to ensure continued compliance to all related regulations. Position Reports To: VP, Quality / Siemens Healthineers POC Responsibilities - Experience with managing complex issues with potential for significant business impact - Exceptional attention to detail with strong organizational and technical skills - Advanced knowledge of FDA regulations, EU IVD Directive and new IVD regulations, pertaining to Quality System regulation (e.g. ISO 13485:2016) - Strong leadership skills - Experience in lean methods like Six Sigma, Agile or Business Systems for operational excellence - Strong analytical skills and data driven mindset - Must manage multiple projects simultaneously - Must have strong written and verbal communication skills, including presentations to senior management - Key leader during site audits including direct interface with investigators Required Knowledge/Skills, Education, and Experience BS/BA in related discipline, or advanced degree (preferred), or equivalent combination of education and experience Typically 10-15 years of successful management experience in Quality field. Experience with FDA Quality System Regulations and audits. Travel may be up to 10% for this position Preferred Knowledge/Skills, Education, and Experience Additional expertise in Quality Systems and Regulatory Affairs is a plus as this role is a high-ranking position within the QT team at POC 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) 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. 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. 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.