QA Analyst
AIQ
CypressSelenium
QA/RA Project Manager
DeepHealth
full-time
Posted on:
Location: Massachusetts, South Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $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.
