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Tier-1 brand, metro location, and mid-level (5+ yrs) role increase competitive density.
Role demands medical-device regulatory and validation expertise, limiting cross-industry transferability.
Explicit 5+ years in regulated medical device quality and mandatory standards/regulatory experience make shortlisting strict.
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Lead and approve software validation deliverables and compliance activities for Non-Product Software supporting Quality Management System and manufacturing process software, ensuring regulatory adherence (21CFR820, 21CFR11, ISO 13485).
Drive software risk management, assessments, classification, and categorization for software such as Camstar, LIMS, SAP, and ETQ.
Support training, audits, change control, and strategic decision-making related to software compliance and emerging technologies (AI/ML, Cybersecurity, Cloud).
Minimum 5+ years experience in software quality engineering or related role within medical device or regulated industry.
Working knowledge of relevant industry standards and regulations (ISO 13485, 21 CFR).
Bachelor’s degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical or related discipline.
Willingness to work shifts supporting US region; occasional travel may be required; role not eligible for visa sponsorship.
Experience operating within regulated medical device or equivalent quality environment with strong focus on regulatory compliance and risk-based software validation.
Ability to collaborate cross-functionally with software testing, validation engineers, and business owners to drive quality assurance and compliance.
Familiarity with Software Development Life Cycle (SDLC) processes, software engineering best practices, and emerging technologies impacting software quality.