Quality Engineer - CARY, NC

Socket.dev; California (MO); 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 time off

Job summary

Siemens Healthineers seeks a Quality Engineer to drive CAPA and document management processes within a medical device context. The role emphasizes leading audits, fostering continuous improvement, and cross-functional collaboration across regions.

Ideal candidates have 3+ years in Quality Management Systems in regulated medical device environments, with Lead Auditor certification preferred and ISO 13485 / FDA knowledge. Travel may be required, and comprehensive benefits are offered.

Qualifications

• Bachelor’s or Master’s degree in Quality, Engineering, Natural Science or related discipline; medical device experience preferred.
• 3+ years in Quality Management Systems; 5–7 years preferred in regulated medical device environments.

Responsibilities

• Actively participate in audits and collaborate with cross-functional teams to improve quality processes.
• Lead internal and supplier audits and coordinate with stakeholders for audit readiness.
• Serve as CAPA Management Process Manager, leading CAPA meetings and supporting CAPA Owners and Quality Managers.

Skills

Auditor Certification

Quality management

Cross-cultural communication

Decision making

Presentations

Travel readiness

Education

Bachelor’s/Master’s in Quality/Engineering/Natural Science

Tools

ISO 13485

FDA 21 CFR QMSR

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 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.

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 Aff… 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.