Quality Engineer - CARY, NC

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.

As a Quality Engineer, help shapethe CSQuality Management System by driving the effectiveness and continuous improvement of CAPA and Document Management process controls.

• Activelyparticipatein audits and partner withcross 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 theend-to-end Corrective and Preventive Action (CAPA) process. Leadcross functionalCAPAmeetings,coachand support CAPA Owners and Quality Managers, moderateCAPA Steering Board meetings, and serve as the Customer ServicesCAPA 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 improveprocess related training materials for assigned processes.

• A Bachelor’s or Master’s degree in Quality, Engineering,Natural Scienceor 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 (e.g., ISO 13485, FDA 21 CFR QMSR) for medical devices.

• Excellent communication skills, with proven intercultural sensitivity and the ability to collaborate effectively across teams and regions.
• Excellent decision-makingability, enabling consensus-building across multiple levels of the organization.
• Customer oriented mindset
• Abilityto develop presentations, tailored to multiple audiences with appropriate levelsof detail and focus based on stakeholder needs.
• Travel required as needed.

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.

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: $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…