$80K — $100K *
We are seeking a Software Quality Engineer with development experience and the ability to work on multiple projects independently and as part of a project team. This person will be an integral part of the both the quality department and development teams contributing to quality plans and design documentation. This candidate will also perform various quality-engineering functions and associated support tasks in driving business objectives, developing knowledge and experience in the areas of ISO13485, 21 CFR 820 and 803 and other relevant standards.
Essential Job Functions
Drive improvements in testing and application lifecycle management.
Create and review quality system documents, protocols, process and product validations, and test methods.
Provide support for quality objectives and process improvement efforts.
Coordinate overall compliance administration activities relating to design controls, verifications, validations and qualifications.
Perform internal quality audits and build / review risk assessments.
Develop and apply knowledge around ISO9001, ISO13485, 21 CFR 820/803, and SaMD.
Identify, implement, and monitor procedures and systems to support relevant standards.
Perform general quality control / quality assurance tasks, support product testing and releases as needed.
Ability to perform engineering work of a broad nature with little direction from Quality Management. Generally, receives mentorship on novel or controversial problems.
Knowledge of medical device regulations, industry or international standards, including management responsibility; IEC 62304 Medical Device Software Life Cycle
Experience with Jira, Redmine, Bugzilla, Jenkins, Git, SVN, TFS/ Azure DevOps Server, DOORS, Testlink or comparable code management, issue tracking, project planning, documentation and repository tools.
Education and Experience:
Bachelor of Science Degree or equivalent experience
5 – 7 years of demonstrated ability in medical device software as well as establishing and upholding software life cycle processes
the very max base salary on this job is 100k
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Valid through: 6/7/2021
$200K — $325K + $30K bonus *
2 days ago