Senior Quality Auditor & CAPA Lead - Medical Devices

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. Responsibilities Actively participate in audits and partner with cross functional teams to strengthen quality processes and foster a culture of continuous improvement. Act as a key audit lead, conducting internal and supplier audits and partnering with stakeholders to support internal and external audit activities. Serve as the CAPA Management Process Manager, owning and overseeing the end-to-end Corrective and Preventive Action (CAPA) process. Lead cross functional CAPA meetings, coach and support CAPA Owners and Quality Managers, moderate CAPA Steering Board meetings, and serve as the Customer Services CAPA process subject matter expert during audits. Proactively manage assigned process changes to ensure timelines are met, while carefully considering user needs, operational impact, and implementation effort when developing or contributing to process updates. Design and continuously improve process related training materials for assigned processes. Requirements A Bachelor's or Master's degree in Quality, Engineering, Natural Science or a related discipline is preferred, with experience in the medical device industry. Minimum 3 years of experience in Quality Management Systems – 5 to 7 years preferred – within a regulated medical device environment in a global acting company. Auditor Certification REQUIRED – Lead Auditor certification preferred. Expert knowledge of applicable standards such as ISO 13485, FDA 21 CFR QMSR for medical devices. Capabilities Excellent communication skills, with proven intercultural sensitivity and the ability to collaborate effectively across teams and regions. Excellent decision-making ability, enabling consensus-building across multiple levels of the organization. Customer oriented mindset. Ability to develop presentations, tailored to multiple audiences with appropriate levels of detail and focus based on stakeholder needs. Travel required as needed. Benefits and Compensation The Base Pay Range for this Position is $89,220 - $122,672. 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 medical, dental, vision, 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 Affiirmative 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 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. #J-18808-Ljbffr Siemens Healthineers