Remote Sr. FDA Design Quality Engineer (SW)

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Job Overview

The Remote Sr. FDA Design Quality Engineer (SW) at Dice is responsible for ensuring that software development processes comply with FDA regulations and quality standards. This role requires overseeing design control activities, conducting risk assessments, and validating software applications to ensure product safety and efficacy. The ideal candidate will possess strong technical skills in software engineering and a deep understanding of regulatory requirements, enabling them to implement quality assurance practices that align with organizational goals and enhance overall product quality.

Job Responsibilities

• Lead and execute design control activities in compliance with FDA regulations for software products.
• Conduct risk management activities and develop risk mitigation strategies for software applications.
• Collaborate with cross-functional teams to ensure adherence to quality standards throughout the software development lifecycle.
• Develop, review, and approve design history files and technical documentation.
• Conduct software validation and verification activities, ensuring compliance with established processes.
• Provide guidance and expertise on software quality best practices to engineering teams.
• Facilitate training sessions on quality processes and FDA requirements for team members.
• Monitor and analyze quality metrics, presenting findings and recommendations to management.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, Biomedical Engineering, or a related field.
• At least 5 years of experience in quality engineering roles, specifically in the medical device or healthcare software industry.
• Strong knowledge of FDA regulations and ISO 13485 standards related to software development.
• Proficient in risk management methodologies, including ISO 14971.
• Experience with software validation and verification processes.
• Excellent analytical and problem-solving skills, with attention to detail.
• Strong communication skills, both written and verbal, to effectively present findings and influence stakeholders.

Technologies & Tools

The Remote Sr. FDA Design Quality Engineer (SW) will utilize a variety of technologies and tools to accomplish their tasks effectively. Familiarity with software quality management systems (QMS), version control systems, project management tools, and validation frameworks is essential. Knowledge of programming languages such as Python or Java may also be beneficial for collaboration with software development teams. Additionally, tools for documentation management and risk assessment will be used to support compliance and quality assurance efforts.

Ideal Candidates

The ideal candidate for this position possesses a passion for quality and compliance in the medical software industry. They are detail-oriented professionals who demonstrate strong analytical skills and the ability to navigate complex regulatory frameworks. An effective communicator, both in collaborating with interdisciplinary teams and in presenting data-driven insights, is crucial. Furthermore, candidates who show initiative, adaptability, and a commitment to continuous improvement within the quality engineering domain will excel in this role.