Overview
Quality Engineer II Jobs in Canton, GA at Search Leaders, LLC
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.
In This Role, You Will:
Assume responsibility for all software quality assurance activities in accordance with Quality System Requirements
Ensure that medical device software complies with all applicable regulatory standards and that software development documentation is developed in accordance with FDA guidance
Design and develop test plans and protocols for software design verification
Execute and document software design verification activities, create and submit test reports and summary documentation
Participate in cross-functional requirements analysis, software risk management activities and contribute to definition and documentation of software requirements
Actively contribute to and collaborate on all software related system validation activities
Contribute to design and implementation of automated testing and continuous integration process
Support creation of regulatory submission documentation and support audit related activities
Support cross-functional team with product cybersecurity assessments
Drive best practices for establishing requirements from user feedback
Identify gaps/improvement opportunities within risk management process
Who You Will Report To:
Director, Software Engineering
Requirements:
Education: Bachelor’s degree is required, preferably in Computer Science, Engineering, Math or a STEM discipline. In addition, 5+ years of relevant experience, preferably in the medical device industry
Alternative, minimum of 7 years professional experience in software quality assurance for products released to and used by customers
Work location: Pleasanton, CA
Travel: <10%
Full time employment
Extensive hands-on experience with design verification process in medical device development
Strong understanding of applicable regulatory standards, e.g., 21 CFR 820, IEC-62304, ISO-13485 and ISO-14971
Experience developing and implementing automated tests for software quality assurance purposes
Expert level knowledge of black- and white-box testing methods
Experience with risk management processes and thorough understanding of FMEA
Ability to identify, analyze and document complex problems through effective use of technical and interpersonal communication skills, take responsibility for and drive actions necessary to resolve issues
Ability to handle conflicting priorities through interpersonal, team, leadership, and negotiation skills
Desirable: Experience with calibration and testing for computer vision imaging pipelines
Desirable: Experience in model-based testing
Compliance with relevant county, state, and Federal rules regarding vaccinations.
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Title: Quality Engineer II
Company: Search Leaders, LLC
Location: Canton, GA
