QA/RA Project Manager - Remote

Overview

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. 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.

In Short

• Lead QARA integration across design controls, risk management, verification/validation, and design transfer phases.
• Partner with Regulatory Affairs for audits, gap assessments, and submission preparations.
• Analyze quality events and drive CAPA implementation.
• Champion process improvements using Lean Six Sigma methods.
• Identify, assess, and mitigate risks related to product quality.
• Serve as QARA lead for product development initiatives.
• Facilitate coordination between engineering, clinical, regulatory, and QA.
• Provide updates to PMO and executive stakeholders on quality status.
• 5+ years of program management experience in regulated industries.
• Strong command of healthcare quality and regulatory standards.

Requirements

• 5+ years of program management experience in SaaS, health tech, or regulated industries.
• Strong command of healthcare quality and regulatory standards.
• Skilled in quality tools and methodologies: FMEA, CAPA, root cause analysis.
• Project Management experience.
• Proficiency in tools like SmartSheet, Jira, Ketryx preferred.
• Experience leading complex projects with QARA deliverables.
• Strong risk management mindset.
• Excellent communication and stakeholder management skills.
• High accountability and problem-solving mindset.
• Bachelor’s Degree required.

Benefits

• Opportunity to work in a cutting-edge field of healthcare technology.
• Flexible work environment with remote options.
• Collaborative and innovative team culture.
• Professional development opportunities.
• Contributions to impactful projects in healthcare.