Katalyst CRO
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Sr. Principal Software Quality Engineer
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Katalyst CRO . Responsibilities Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development Framework (SPDF) and software security best practices. Support Agile software development teams, ensuring regulatory and quality compliance. Own and resolve CAPAs related to design control and software quality processes.
Requirements
8+ years in medical device software quality engineering. Deep knowledge of 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, IEC 60601, and cybersecurity standards. Strong experience in SaMD, SiMD, cloud-based software, AI/ML, and security risk management. Hands-on experience with design control documentation, risk management, and DHF oversight. Proficiency in Microsoft Office, Azure DevOps, statistical tools (e.g., Minitab), and vulnerability scanning. Preferred: ASQ CQE, Six Sigma Black Belt/Green Belt, ISO/IEC 27001, cloud infrastructure expertise.
Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing
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Sr. Principal Software Quality Engineer
role at
Katalyst CRO . Responsibilities Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development Framework (SPDF) and software security best practices. Support Agile software development teams, ensuring regulatory and quality compliance. Own and resolve CAPAs related to design control and software quality processes.
Requirements
8+ years in medical device software quality engineering. Deep knowledge of 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, IEC 60601, and cybersecurity standards. Strong experience in SaMD, SiMD, cloud-based software, AI/ML, and security risk management. Hands-on experience with design control documentation, risk management, and DHF oversight. Proficiency in Microsoft Office, Azure DevOps, statistical tools (e.g., Minitab), and vulnerability scanning. Preferred: ASQ CQE, Six Sigma Black Belt/Green Belt, ISO/IEC 27001, cloud infrastructure expertise.
Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr