QA/RA Project Manager
DeepHealth
QA/RA Project Manager
DeepHealth
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts, South Carolina
Visit company websiteSalary
💰 $85,000 - $95,000 per year
Job Level
Mid-LevelSenior
About the role
- The QA/RA Project Manager plays a critical role at the intersection of product development, quality assurance, and regulatory compliance.
- Reporting into the PMO, this position 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.
- 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 preparation of submissions (FDA 510(k), CE Mark, etc.).
- Analyze quality events, lead root cause investigations, and drive CAPA implementation and closure in collaboration with product teams.
- Champion process improvements using Lean Six Sigma methods to reduce defects, enhance reliability, and streamline compliance workflows.
- Identify, assess, and mitigate risks related to product quality, safety, and regulatory timelines.
- Serve as QARA lead for product development initiatives; ensure alignment of QARA activities with phase-gate milestones.
- Facilitate coordination between engineering, clinical, regulatory, and QA to resolve blockers and meet program targets.
- Provide clear, timely updates to the PMO and executive stakeholders on quality status, risks, and dependencies.
- This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.
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.
- Healthcare & Domain Knowledge.
- 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 .
