Entry - level Junior Software Engineer at Upstream Impact focusing on QA, reliability, and software development processes. Collaborating in a small team to improve product quality through testing and operational support.
About the role
- Quality Engineer managing QA processes for a medical device company developing software as medical devices. Ensuring compliance and leading quality initiatives across engineering and clinical teams.
Responsibilities
- Manages and supports Controlled Documents on Welldoc’s electronic QMS (eQMS) and Learning Management System (LMS).
- Play the role of a Quality Lead on product development core teams to advocate QMS requirements and to provide guidance to the project team.
- Provide, improve, and maintain quality methodologies, processes, and procedures.
- Support continuous improvement initiatives and projects to improve processes and upgrade Welldoc’ s QMS.
- Establish and maintain effective cross-functional team communications to advance quality.
- Proactively provide inputs to develop a master plan for Welldoc’ s for our quality initiatives and objectives.
- Improving key aspects of our quality systems as part of daily tasks.
- Contribute to QMS management reviews in a timely and effective manner.
- Interface with Quality Assurance / Quality System peers in external partner organizations.
- Manage and support internal and external audits and inspections, ensuring compliance with regulations.
- Partner with R&D, Engineering, Clinical, etc., in the development of new products.
- Maintain and update training programs and manage the configuration of controlled documents.
Requirements
- 5+ years’ experience with FDA and ISO 13485 regulated medical device product development
- Practical knowledge or experience with design controls, production, and process controls, CAPA, complaint handling, and post-market / vigilance requirements
- Experience with MDSAP, ISO 13485, ISO 14971, 21 CFR 820, FDA QSR, Health Canada, TGA, and EU MDR.
- Ability to author, review, and update technical or QMS documents.
- Experience with software verification, validation, and software hazards analysis.
- Experience or practical knowledge of IEC 62304 and agile methodologies is preferred.
- Experience with software quality and software as a Medical Device (SaMD) is a plus
- Attention to detail and meticulous record-keeping.
- Ability to work both independently and as part of a highly integrated team.
- Multitasking and project organization skills are a must
- Excellent communication and problem-solving skills
- Comfortable working in a fast-paced and agile environment with distributed teams across different time zones
Benefits
- generous PTO
- medical insurance
- opportunities for employee development and advancement
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Principal Software Quality Engineer managing quality for Red Hat’s OpenShift Container Platform. Overseeing execution of quality strategy and leading test automation framework development.
Senior Software Test Analyst developing automated testing solutions for backend applications. Collaborating with development teams to ensure quality and project success at Instituto de Pesquisas Eldorado.
QA Lab Operations Engineer overseeing physical and virtual lifecycle of lab environments for AI edge cloud provider Zadara.
Quality Assurance Specialist at Bernoulli leading manual testing and automation strategies for web applications, ensuring reliability and user - centric solutions.
QA Analyst supporting quality processes and teams at Compass UOL. Engaging in quality assurance practices and team collaborations.
QA Tester performing functional and quality assurance testing for Astor & Sanders Corporation, an award - winning IT solutions provider located in McLean, VA.
Full - Stack QA Engineer at IDT Corporation developing automated testing frameworks for web applications. Collaborating with cross - functional teams in Scrum to ensure high - quality software delivery.
Software Engineering Intern at Verisk focusing on both software development and quality assurance to gain hands - on experience. Collaborate on projects while enhancing understanding of the software lifecycle.
Senior Software Quality Assurance Specialist supporting implementation of management systems at Velsera. Collaborating across teams in the product life cycle within a hybrid work environment.