Support software product teams by guiding them through internal quality processes and documentation requirements.
Participate in risk assessments, quality document reviews, design review and change control processes to ensure quality impacts are considered and addressed.
Ensure development activities align with applicable regulatory and compliance frameworks (e.g., SOC 2, ISO 27001, FDA 21 CFR Part 11, HIPAA, ISO 13485).
Lead SOC 2 compliance activities and support internal and external audits.
Support internal and external SOC2 audits
Ensure that cloud system validation and software lifecycle deliverables meet applicable standards and company policies.
Collaborate with leadership and cross-functional teams to identify process gaps and implement continuous improvements across the SDLC
Maintain and improve quality system documentation, including SOPs, work instructions and guidance documents.
Requirements
Bachelor’s degree in Software Engineering, Computer Science, or a related field.
6+ years of experience in software quality or quality systems role, supporting cloud-based or SaaS products.
Strong understanding of software development lifecycles (SDLC) and how quality assurance fits into each stage
Experience with cloud platforms, preferably Microsoft Azure or AWS
Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards
Solid understanding of quality systems, audits, software change control and statistical analysis.
Benefits
salary plus bonus eligible
generally eligible for short-term and long-term financial incentives
benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality assurancesoftware development lifecyclestatistical analysiscloud system validationchange controlSOPswork instructionsguidance documents