Skip to main content

Design Assurance & Quality Engineer

Remote

Postularse
ID de la oferta 59492 Área funcional Seguro de calidad Tiempo completo/tiempo parcial Tiempo completo Nivel de experiencia Profesionales

Design Assurance & Quality Engineer

[title]
Design Assurance & Quality Engineer
Permanent  

Creating foldable displays, advancing medical innovations, or giving new life to precious metals – at Heraeus, we empower our customers to stay ahead of the curve. As a family-owned global technology leader, we take pride in being the invisible force driving innovation. Whether in production, research, sales, or administration, we deliver world-class quality across key industries: Metals & Recycling, Healthcare, Semiconductor & Electronics, and Industrials. With a strong global presence, including a significant footprint in the United States, Heraeus employs approximately 15,200 people across 40 countries, all dedicated to shaping the future of technology and industry. 

About Heraeus

Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and technological leadership to create the most diverse products, all with one thing in common: World-class quality. Working with customers around the world, we shape the future and provide vital innovations in the areas of Metals & Recycling, Healthcare, Semiconductor & Electronics and Industrials. Heraeus is one of the top 10 family-owned companies in Germany and has a team of around 17,200 employees in 40 countries.

About Engineered Tissue Solutions

Engineered Tissue Solutions was acquired in 2021 by the Heraeus Group, a broadly diversified family-owned technology company. Learn more about Heraeus Group at www.heraeus.com.

The following challenges await you:

Design Assurance Duties

  • Lead and implement product development, including the application of design controls, for new products and existing product changes including line extensions.
  • Create and maintain the design history file (DHF), including development of related specifications such as user requirements and design specifications.
  • Plan, implement, and report on design verification and validation studies, including bench and pre-clinical test protocols and reports.
  • Lead the development of manufacturing documentation and manufacturing process validation activities.
  • Responsible for risk management activities from product concept through commercialization.
  • Partner with Regulatory to support submissions for pre-market authorizations in the US.
  • Work closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirements.

Quality System Duties

  • Perform lot release, including reviewing batch records, device history records (DHRs), and process documentation for accuracy and completeness.
  • Support the intake, evaluation, and documentation of nonconforming materials.
  • Support post-market phase including product complaint handling, risk management, and post-market surveillance activities.
  • Help conduct supplier qualification and performance evaluation activities.
  • Communicate quality issues to suppliers and support resolution tasks.
  • Assist with internal audits and support external audits and inspections (e.g., FDA, ISO).
  • Participate in CAPA investigations and track CAPA progress through verification of effectiveness.
  • Help provide QMS training and subject matter support for fellow employees.
  • Administer user set up and employee training in QMS support software and monitor training.
  • Serve as document control coordinator in QMS support software.
  • Identify opportunities to improve processes, reduce defects, and enhance overall product quality.
  • Monitor and trend quality metrics and escalate signals.

Your Profile:

  • Bachelor’s degree in life sciences, material sciences, engineering or a related field required.
  • Experience in medical device industry required; minimum 3 years preferred.
  • Working knowledge of design controls and general knowledge of the ISO 13485 standard; formal ISO 13485 training is a plus.
  • Experience in a small company or start-up environment preferred.
  • Experience with QMS support software / document control systems is a plus.

Curious? Apply now!

Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating a workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.   

We participate in E-Verify to confirm employment eligibility after hire. Learn more at www.e-verify.gov


Any further questions?

If you need any assistance or have questions, please contact hrdirect-americas@heraeus.com or visit our website at jobs.heraeus.com.

Keywords: Design Assurance Engineer, Quality Engineer, medical device 


ReqID: 59492
Postularse
Explorar ubicación

Contenido Relacionado

¡Recibe nuevos empleos por correo electrónico!

Nuestras ofertas de empleo – adaptadas a ti

Me interesa:Por favor, selecciona una categoría o una opción de ubicación. Haz clic en "Añadir" para crear tu alerta de empleo.

*Al enviar tu información, reconoces que has leído nuestra política de privacidad y aceptas recibir comunicaciones por correo electrónico de Heraeus.