- Beckman Coulter Diagnostics (Miami, FL)
- …Validation Plan and support of the MVP strategies.This position is part of the Quality Assurance - Validation department located in Chaska, MN and will be on-site. ... at a Time.You will be a part of the Quality Assurance - Validation team and report to the...years of experience, OR Doctoral degree in fieldExperience in software , test method, equipment, process, and/or design testing methodologies.Knowledge… more
- Abbott (San Diego, CA)
- …combination of education and work experience. + Minimum 7 years of Software Quality Engineering experience. + Detailed knowledge of FDA , GMP, IEEE 1012 and ... Diego, CA location. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering… more
- Abbott (Sylmar, CA)
- …combination of education and work experience. + Minimum 7 years of Software Quality Engineering experience. + Detailed knowledge of FDA , GMP, IEEE 1012 and ... or irregular heartbeats. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality … more
- Edwards Lifesciences (Naperville, IL)
- …to work independently and proactively in a fast-paced environment. + Prefer experience with FDA guidelines for Software Quality and Systems Validation is a ... collaboration with the Sustaining Engineer and Product Owner, this position provides technical/ software expertise to the product team. This position works on both… more
- Abbott (Sylmar, CA)
- …with heart arrhythmias, or irregular heartbeats. We are seeking a high caliber ** Software Quality Engineer I.** This position is responsible for executing and ... typical to meet the skills and responsibilities of the position. + Knowledge of FDA Quality System Requirements and other applicable US Code of Federal… more
- Abbott (Sylmar, CA)
- …Our location in **Sylmar, CA** , currently has an opportunity for a ** Software Quality Engineer II** **.** This position is responsible for executing ... integrity risks. + Follow approved Design Control procedures for software development in accordance with FDA guidelines....education and work experience + Minimum 2 years + Software Quality Engineering experience + Prior medical… more
- J&J Family of Companies (Santa Clara, CA)
- …GxP requirements and experience in non-product software validations. + Knowledge of quality system requirements including familiarity with US FDA 21 CFR Part ... Description:** Johnson & Johnson is hiring for a **Principal Quality Compliance Software Specialist - Shockwave Medical...and maintains local standard operating procedures to follow all FDA /EU/ISO regulations, as well as Corporate quality … more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... understanding of medical device software standards such as IEC 62304. ** Software Quality Engineering Expertise:** 1. Hands-on experience in Software … more
- Abbott (Burlington, MA)
- …health and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance ... oversight for Software Development projects. The **_Staff Software Quality Engineer_** is responsible for executing...FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and… more
- Stryker (Portage, MI)
- **Stryker** is hiring a **Manager, Software Design Quality ** to manage a team of Design Quality engineers that work on Software as a Medical Device ... do:** + Manage and develop a team of design quality engineers supporting Software as a Medical...including direct interaction with regulatory agencies such as the FDA , MoH, and TUV. + Experience with software… more
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