Katalyst CRO ยท 2 months ago
Sr. Principal Software Quality Engineer
Bellevue, WA
Contract
Hybrid
Senior Level, Lead/Staff
8+ years expKatalyst Healthcares & Life Sciences is seeking a Sr. Principal Software Quality Engineer who will provide technical leadership for product quality and software quality assurance in the medical device industry. The role involves overseeing quality engineering activities, leading design control and risk management, and ensuring compliance with industry standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Provide Quality Engineering leadership to product development teams for both hardware and software
Lead Design Control and Risk Management activities (plans, hazard analyses, dFMEA/pFMEA, RMF reports)
Oversee and approve Design History File (DHF) documentation, including design inputs/outputs, V&V, and test planning/protocols
Serve as Software Quality SME guiding code reviews, software security analysis, and software BOM
Lead implementation of software quality best practices and compliance processes
Support transfer to manufacturing, ensuring product quality continuity during launch and field deployment
Provide quality oversight and guide resolution of software bugs, anomalies, and cybersecurity vulnerabilities
Implement Quality System updates based on new regulations or standards
Lead CAPA resolution and closure related to design control processes
Support released products and collaborated with customer support as needed
Contribute to continuous process improvement and other QA initiatives as directed by management
Qualification
Required
B.S./M.S. in Engineering (Biomedical, Software, Electrical, or related field) or equivalent scientific discipline
8+ years of progressive Quality Engineering experience in the medical device industry
Strong working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366
Hands-on experience with hardware/software design, verification, validation, and electromechanical device testing
Expertise in statistical tools and data analysis (e.g., Minitab)
Proven ability to manage multiple projects and drive quality and compliance culture
ASQ CQE and/or Six Sigma (Black/Green Belt) certification
Experience with AI/ML, AAMI TIR45, SaMD, and cloud infrastructure quality systems
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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