DeepHealth

QA/RA Project Manager

DeepHealth

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts, South Carolina

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Salary

💰 $85,000 - $95,000 per year

Job Level

Mid-LevelSenior

About the role

  • Play critical role at intersection of product development, quality assurance, and regulatory compliance.
  • Lead QARA workstreams aligned to product lifecycle (PLM); ensure safety, quality, regulatory readiness of DeepHealth's medical device software and digital health solutions.
  • Lead QARA integration across design controls, risk management, verification/validation (V&V), and design transfer phases.
  • Partner with Regulatory Affairs to support audits, gap assessments, and regulatory submissions (FDA 510(k), CE Mark, etc.).
  • Analyze quality events, lead root cause investigations, and drive CAPA implementation and closure.
  • Champion continuous improvement using Lean Six Sigma; reduce defects and streamline compliance workflows.
  • Serve as QARA lead for product development initiatives; ensure alignment with phase-gate milestones.
  • Facilitate coordination between engineering, clinical, regulatory, and QA to resolve blockers and meet program targets.
  • Provide updates to PMO and executive stakeholders on quality status, risks, and dependencies.
  • Remote role with ~5-10% travel; US-only remote with multiple US city options.

Requirements

  • 5+ years of program management experience, ideally in SaaS, health tech, or similarly regulated industries.
  • Strong command of healthcare quality and regulatory standards: ISO 13485, FDA 21 CFR Part 11/820, IEC 62304, EU MDR.
  • Skilled in quality tools and methodologies: FMEA, CAPA, root cause analysis, SPC, Six Sigma.
  • Project Management.
  • Proficiency in tools like SmartSheet, Jira, Ketryx preferred.
  • Experience leading complex, multi-disciplinary projects with QARA deliverables.
  • Strong risk management mindset and execution ability.
  • Familiarity with clinical environments and patient safety best practices.
  • Experience in medical device, imaging, or remote patient monitoring preferred.
  • Excellent communication and stakeholder management across technical and non-technical teams.
  • Ability to lead without authority and influence outcomes across functions.
  • High accountability, problem-solving mindset, and detail orientation.
  • Microsoft Office experience required.
  • Bachelor’s Degree.