QARA Project Management

The QARA 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. The role demands strong project leadership, technical fluency in regulatory frameworks, and the ability to drive cross-functional alignment across R&D, regulatory, clinical, and operations teams.

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.

PLEASE NOTE:  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.

Minimum Qualifications, Education and Experience 

Technical Expertise

• 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.

Soft Skills

• 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.

Physical Demands

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time).

Working Environment

Remote

ACCOMMODATIONS
Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.