Quality Engineer

Regulatory Jobs; Cary (NC); Presencial; USD 89 000 - 123 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

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

Resumo da oferta

Siemens Healthineers is seeking a Quality Engineer to drive CAPA effectiveness and document management controls within the CS Quality Management System. You will lead CAPA meetings, coach CAPA Owners, and support audits across internal and supplier networks.

The role requires a BS/MS in quality or engineering, 3+ years in a regulated medical device setting, and Lead Auditor certification. Travel may be required; base pay ranges are provided by the employer.

Qualificações

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

Responsabilidades

• Actively participate in audits and partner with cross functional teams to strengthen quality processes.
• Lead internal and supplier audits and support audit activities.
• Own and oversee the CAPA management process and lead CAPA meetings.
• Manage process changes with attention to timelines and user impact.
• Design and continuously improve training materials for assigned processes.

Conhecimentos

Auditing

Communication skills

Cross-functional collaboration

Presentation skills

Travel

Formação académica

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

Descrição da oferta de emprego

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.

Benefits

• 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 Affi… 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.

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.

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