Quality Engineer - CARY, NC

Siemens Healthineers; Cary (NC); 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

Paid Parking

Paid Time Off

Paid Sick Time

Job summary

Siemens Healthineers is seeking a Quality Engineer to strengthen the CS Quality Management System and drive CAPA and document management improvements. The role centers on audits, cross-functional collaboration, and process optimization for medical devices.

You will lead CAPA activities, coach teams, and design training materials while ensuring regulatory compliance and continuous improvement across global operations.

Qualifications

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

Responsibilities

• Act as key audit lead; conduct internal and supplier audits with stakeholders.
• Own and oversee the CAPA process; lead CAPA meetings across functions.
• Coach CAPA Owners and Quality Managers; support CAPA Steering Board.
• Develop and refine process training materials for assigned areas.
• Manage process changes; balance timelines with user needs and impact.

Skills

Auditing

CAPA Management

Document Control

ISO 13485

FDA QMSR

Quality Systems

Cross-functional

Communication

Education

Quality/Engineering degree

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 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.RequirementsA 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.CapabilitiesExcellent 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 mindsetAbility to develop presentations, tailored to multiple audiences with appropriate levels of detail and focus based on stakeholder needs.Travel required as needed.#LI-JW1Who 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 - $122,672Factors 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 Affirmative 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 are 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.