Sr. Software Quality & Compliance Engineer (MedTech)

TL;DR

Sr. Software Quality & Compliance Engineer (MedTech): Spearheading Computer System Validation (CSV) and AI integration into quality frameworks for precision cancer genomics with an accent on regulatory compliance and risk management. Focus on ensuring software products meet FDA, ISO, and IEC standards while automating quality oversight.

Location: Hybrid in Fremont, CA (Onsite Monday, Tuesday, and Thursday)

Salary: $130,000 – $155,000

Company

hirify.global is a leader in advanced cancer genomics, providing precision cancer therapies and diagnostics via the hirify.global NeXT Platform.

What you will do

• Drive end-to-end GAMP 5 validation lifecycle for internal software and cloud-based platforms.
• Ensure continuous compliance with FDA 21 CFR Part 11, 21 CFR 820, EU Annex 11, and IEC 62304 standards.
• Conduct proactive risk assessments (FMEA) and implement mitigation strategies across the SDLC.
• Integrate AI-driven tools into the QMS and develop risk-based frameworks for AI validation.
• Manage eQMS modules including Document Control, CAPA, and Change Management.
• Serve as the primary Subject Matter Expert during internal and external regulatory audits.

Requirements

• BS in Computer Science or equivalent experience.
• 5-8 years of experience in SQA or Compliance within Diagnostics, MedTech, Pharma, or Biotech.
• Proven expertise in Computer System Validation (CSV) and maintaining a validated state.
• Hands-on experience with eQMS platforms such as MasterControl, Veeva, Arena, or ETQ Reliance.
• Deep knowledge of SDLC methodologies (Agile, V-Model) and quality resolutions (NC, CAPA).
• Strong working knowledge of AI/ML principles for compliant application within a QMS.

Nice to have

• Hands-on experience with global frameworks: FDA, IVDR (EU 2017/746), or MDR (EU 2017/745).
• Exceptional communication skills for translating regulatory requirements into actionable guidance.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) match and Employee Stock Purchase Plan (ESPP).
• Tuition reimbursement and wellness benefits.
• Onsite gym, commuter benefits, and EV charging stations.
• Annual performance-based bonus and long-term incentive units (equity).