Quality Engineer - CARY, NC

Quality Engineer

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 shape the CS Quality Management System by driving the effectiveness and continuous improvement of CAPA and Document Management process controls.

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 (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.
• 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.