Quality Engineer - CARY, NC

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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 drivingthe effectivenessand continuous improvement of CAPA and Document Management process controls.

Responsibilities:



* Activelyparticipatein audits and partner withcross functionalteams 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-endCorrective 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 relatedtraining materials for assigned processes.

Requirements



* A Bachelor's orMaster's degree inQuality, 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 environmentin 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.

Capabilities



* Excellent communication skills, with proven intercultural sensitivity and the ability to collaborate effectively across teams and regions.



* Excellentdecision-makingability, enabling consensus-building across multiple levels of the organization.



* Customer orientedmindset



* Abilityto develop presentations, tailored to multiple audiences withappropriate levelsof detail and focus based on stakeholder needs.



* Travel required as needed.

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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 becom...