Quality Engineer - CARY, NC

Siemens Healthineers AG; United States; On-site; USD 89,000 - 123,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Parking/Public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers is hiring a Quality Engineer in the United States to shape the CSQuality Management System by driving CAPA and Document Management process controls.

You will lead internal and supplier audits, guide CAPA meetings, and ensure end‑to‑end CAPA effectiveness while coordinating cross‑functional teams and training material design. Travel may be required as needed.

Qualifications

• Bachelor’s or Master’s degree in Quality, Engineering, Natural Science or related discipline.
• Minimum 3 years in Quality Management Systems with 5–7 years preferred in a regulated medical device environment.
• Auditor Certification REQUIRED; Lead Auditor certification preferred.
• Expert knowledge of ISO 13485 and FDA 21 CFR QMSR for medical devices.

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 end‑to‑end CAPA, leading cross functional CAPA meetings and coaching CAPA Owners.
• Proactively manage assigned process changes to meet timelines while considering user needs and impact when developing updates.
• Design and continuously improve process related training materials for assigned processes.

Skills

Auditor Certification

Lead Auditor Certification

CAPA Management

Audit Leadership

Cross-functional Collaboration

Education

Bachelor's or Master's in Quality/Engineering/Natural Science

Job description

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 CSQuality 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 levelsof detail and focus based on stakeholder needs.

• Travel required as needed.

#LI-JW1

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 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 of the Company’s plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• medical insurance
• dental insurance
• vision insurance
• 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 affirmatively action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their 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.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice

California residents have the right to receive additional notices about their personal information. To learn more, click here.

Export Control

“A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

Data Privacy

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

Beware of Job Scams

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you’re concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

To all recruitment agencies

Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.