Quality Engineer

July 25

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Sword Health

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Digital Health • medical devices • machine learning • Artificial Intelligence • physical therapy

201 - 500

Description

• Develop and implement quality assurance processes and procedures specific to software development for medical device. • Guide product development teams through our QMS and Software Engineering Lifecycle process to ensure software is developed in compliance with internal procedures as well as FDA and ISO and other regulatory bodies requirements. • Conduct evaluation of software engineering activities of medical device new product development including requirements, software risk analysis, and design, development, documentation, integration, verification, validation and release activities to deliver medical devices that are safe, secure and effective. • Provide quality engineering input to impact the design, coding, and debugging of software in various coding languages including SOUP software. • Support software build, maintenance, defect management, and change control activities. • Stay updated and provide guidance on relevant industry standards, regulations, and guidelines to ensure compliance throughout the software development lifecycle. • Collaborate with cross-functional teams to identify, assess, and mitigate risks associated with software development for medical devices. • Plan, coordinate, and execute software verification and validation activities to ensure the accuracy and completeness of software requirements. • Prepare and maintain accurate and comprehensive documentation related to software quality activities, including reports, test plans, and risk assessments. • Work closely with software development teams to provide guidance on quality-related matters and facilitate effective communication between teams. • Conduct root cause analysis for software-related quality issues and implement corrective and preventive actions (CAPAs) as necessary. • Provide training and support to internal teams on quality-related processes and procedures related to software development.

Requirements

• Bachelor's degree in Science, Engineering or related discipline. • 3+ years of experience in Quality Software Engineering or a related role within a regulated environment, preferably in medical devices or pharmaceuticals. • Experience in medical device new product development preferred. • Ideally, relevant work experience in Software quality management of medical devices including Software as Medical Device (SaMD). • Strong knowledge of software development lifecycle processes and best practices (e.g Agile, Waterfall). • Familiarity with relevant quality standards and regulations: Quality Management System ISO 13485, SiMD IEC 62304, SaMD IEC 82304, FDA 21 CFR 820.30, FDA CFR part 11 Compliance, knowledge and experience with FDA General Principles of Software Validation, IEC 14971 Risk Management, IEC 81001-5-1 Health Software and Health IT Systems Safety, Effectiveness and Security, UL 2900-1 Cybersecurity Standard for Medical Devices. • Experience with risk management methodologies (e.g. FMEA). • Excellent analytical, problem-solving and communication skills. • Experience with Agile, Jira, Confluence preferred. • Fluent in English.