Quality Engineer - CARY, NC

Siemens Healthineers

1d•$91,850 - $126,291

About The Position

The Quality Engineer helps shape the Customer Services Quality Management System by driving the effectiveness and continuous improvement of CAPA and Document Management process controls. The role works with cross-functional teams to strengthen quality processes and support a culture of continuous improvement in a regulated medical device environment. The position owns and oversees the end-to-end Corrective and Preventive Action (CAPA) process, including leading cross-functional CAPA meetings, coaching and supporting CAPA Owners and Quality Managers, moderating CAPA Steering Board meetings, and serving as the Customer Services CAPA process subject matter expert during audits. It also leads internal and supplier audits, supports other internal and external audit activities, manages assigned process changes, and develops and improves training materials for assigned processes. Travel is required as needed.

Requirements

Minimum 3 years of experience in Quality Management Systems within a regulated medical device environment in a globally operating company; 5 to 7 years is preferred.
Auditor certification is required.
Expert knowledge of applicable medical device standards, such as ISO 13485 and FDA 21 CFR QMSR.
Excellent communication skills, intercultural sensitivity, and ability to collaborate effectively across teams and regions.
Excellent decision-making ability and capacity to build consensus across multiple organizational levels.
Customer-oriented mindset.
Ability to develop presentations tailored to multiple audiences and stakeholder needs.

Nice To Haves

Bachelor’s or Master’s degree in Quality, Engineering, Natural Science, or a related discipline is preferred.
Lead Auditor certification is preferred.
5 to 7 years of Quality Management Systems experience is preferred.

Responsibilities

Participate in audits and partner with cross-functional teams to strengthen quality processes and foster continuous improvement.
Conduct internal and supplier audits and partner with stakeholders to support internal and external audit activities.
Serve as the CAPA Management Process Manager, owning and overseeing the end-to-end CAPA process.
Lead cross-functional CAPA meetings and 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.
Manage assigned process changes proactively to meet timelines while considering user needs, operational impact, and implementation effort.
Design and continuously improve process-related training materials for assigned processes.
Travel as needed.