Full-Time QA/RA Project Manager

The QA/RA Project Manager leads QARA workstreams aligned to the product development lifecycle (PLM), ensuring that Deephealth’s medical device software and digital health solutions meet the highest standards of quality, safety, and regulatory readiness. The role demands strong project leadership, technical fluency in regulatory frameworks.

• Quality Assurance & Compliance:
• Product Lifecycle Oversight: Lead QARA integration across design controls, risk management, verification/validation (V&V), and design transfer phases.
• Regulatory Alignment: Partner with Regulatory Affairs to support audits, gap assessments, and preparation of submissions (FDA 510(k), CE Mark, etc.).
• Defect & CAPA Management: Analyze quality events, lead root cause investigations, and drive CAPA implementation and closure in collaboration with product teams.
• Continuous Improvement: Champion process improvements using Lean Six Sigma methods to reduce defects, enhance reliability, and streamline compliance workflows.
• Risk & Issue Management: Identify, assess, and mitigate risks related to product quality, safety, and regulatory timelines.

• Project & Program Execution:
• PLM Program Support: Serve as QARA lead for product development initiatives; ensure alignment of QARA activities with phase-gate milestones.
• Cross-functional Leadership: Facilitate coordination between engineering, clinical, regulatory, and QA to resolve blockers and meet program targets.
• Reporting & Communication: Provide clear, timely updates to the PMO and executive stakeholders on quality status, risks, and dependencies.

• 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.
• 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.
• High accountability, problem-solving mindset, and detail orientation.
• Bachelor’s Degree.

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