Careers that Change Lives
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Design Quality Assurance and help shape policies that change lives.
Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.
A Day in the Life
As a Design Quality Engineer, you will be taking an active part in the development of the company’s products, by ensuring that design control is properly maintained and executed, released products meet performance expectations, and changes to current product designs and service/repair of products in the field, follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies
You will manage the risk management activities from the early stages of the development process and throughout the product lifecycle.
You will review and approve product Verification and Validation strategy
You will review and approve design documents and processes in accordance with Design Controls standards and company’s policies.
You will track product Standards to guide others on their correct implementation.
You will Implement statistical tools usage in R&D, e.g. Cpk, MSA, DOE.
BSc Engineering degree or higher
At least 2 years prior experience related to design quality in a medical device company
Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Directive
Experience in risk evaluation techniques, e.g. FMEA, fault tree analysis
Reliability analysis and test methods
Working knowledge of software and electrical medical devices related standards, IEC62304, IEC 60601, usability and human factors standards
Demonstrated scientific analysis abilities
Nice to Haves
6 sigma Certificate is an advantage