Quality Engineer - CARY, NC

563d Siemens Medical Solutions USA, Inc.; 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

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers is seeking a quality professional to lead internal and supplier audits, manage CAPA processes, and drive continuous improvement in medical device quality systems. This role requires cross-functional collaboration and strong communication across regions.

Able to coach CAPA owners, support audit activities, and develop training materials to improve process compliance and efficiency. Travel as needed.

Qualifications

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

Responsibilities

• Lead audits and partner with cross-functional teams to strengthen quality processes and foster continuous improvement.
• Act as a key audit lead for internal and supplier audits and support audit activities.
• Own and oversee the end-to-end CAPA process and lead CAPA meetings.
• Coach CAPA Owners and Quality Managers; moderate CAPA Steering Board meetings during audits.
• Develop and continuously improve training materials for assigned processes.

Skills

Auditing

CAPA management

Cross-functional collaboration

Audit planning

Intercultural communication

Education

Bachelor’s/Master in Quality, Engineering or related

Tools

QMS

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.

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

• 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.

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.

• 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 AffirAll 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.

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.

California Privacy Notice: California residents have the right to receive additional notices about their personal information.

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.

We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in‑vitro and in‑vivo diagnostics to image‑guided therapy and innovative cancer care, is crucial for clinical decision‑making and treatment pathways.

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.