Design Assurance & Quality Engineer

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.