What are the responsibilities and job description for the Quality Assurance Engineer position at Katalyst HealthCares and Life Sciences?
We are seeking an experienced Quality Assurance Engineer to join our team at Katalyst HealthCares and Life Sciences. This role is responsible for ensuring products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
The ideal candidate will have a Bachelor's degree in Engineering or a related field and at least 6 years of experience in Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related fields. They will also possess extensive hands-on experience with the ISO 14971 standard and knowledge of 21 CFR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
This position requires a strong understanding of risk management requirements, tools, methodologies, and processes. The successful candidate will be able to ensure the systematic and logical conversion of customer requirements to product specifications and post-surveillance codes.
Katalyst HealthCares and Life Sciences offers a collaborative work environment with opportunities for professional growth and development. We are committed to delivering high-quality products and services that meet the needs of our customers.
