Senior Design Quality Engineer

Careers that Change Lives

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation.

Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.

Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.

The Design Quality Engineer (DQE) is accountable for oversight of system, hardware and software quality and risk management throughout the product life cycle.

Provides oversight of the design control to ensure that all design requirements are effectively met.

Assure Company compliance to FDA and ISO 13485 Design Control requirements.
Support Product development team for new and changed products and projects.
Represents quality interests and concerns on project teams.

A Day in the Life

Supporting activities required to ensure quality of the design through compliance with design controls.
Review and approve product design documents in accordance with Design Controls standards and company’s policies, including design V&V activities, DMR and DHR for NPI and Change requests.
Ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards (work with R&D).
Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis, and design change per company and regulatory requirements.
Supports audits and compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are met.
Support continuous improvements activities to reduce product failure rates.
Future of Work

In this role you will be able to work in a Hybrid Work Model. Talk about this with your interviewer for more information.

Must Have:

Degree in Engineering field or second degree in felids of quality and statistics.

Proven experience in Quality system and medical device.

Experience working in an FDA and ISO 13485 regulated environment.

English – read and write.
Nice to have:

Previous experience working in a cross-functional team environment
Familiar with IEC 60601 and product-specific industry standards.
Lean Green Belt or Black Belt