EX Squared is hiring a QA/RA Project Manager

Jobgether is seeking a QA/RA Project Manager to oversee quality assurance and regulatory activities across the entire product development lifecycle for our medical device software and digital health solutions. In this role, you will lead QARA workstreams, manage risks and issues, implement continuous improvement initiatives, and provide clear reporting to executive stakeholders.

What You'll Do

• Lead quality assurance and regulatory integration across design controls, risk management, verification/validation, and design transfer phases.
• Partner with Regulatory Affairs to support audits, gap assessments, and regulatory submissions such as FDA 510(k) and CE Mark.
• Manage defect analysis, root cause investigations, and CAPA implementation to ensure resolution and closure.
• Champion continuous improvement initiatives using Lean Six Sigma methods to enhance product reliability and compliance workflows.
• Identify, assess, and mitigate risks related to product quality, safety, and regulatory timelines.
• Serve as the QARA lead for product development initiatives, ensuring alignment with phase-gate milestones.
• Facilitate cross-functional coordination between engineering, clinical, regulatory, and QA teams to resolve blockers and meet program targets.
• Provide timely reporting on quality status, risks, and dependencies to the PMO and executive stakeholders.

What We're Looking For

• 5+ years of program/project management experience in SaaS, health tech, or similarly regulated industries.
• Strong knowledge of healthcare quality and regulatory standards: ISO 13485, FDA 21 CFR Part 11/820, IEC 62304, EU MDR.
• Proficiency in quality tools and methodologies: FMEA, CAPA, root cause analysis, SPC, Six Sigma.
• Skilled in project management with experience leading complex, multi-disciplinary projects.
• Familiarity with clinical environments, patient safety best practices, and medical device or remote patient monitoring systems.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Ability to lead without direct authority, drive outcomes, and manage risk effectively.
• Detail-oriented, high accountability, problem-solving mindset.
• Bachelor’s degree required.
• Microsoft Office proficiency essential.

Nice to Have

• Proficiency in tools like SmartSheet, Jira, or Ketryx.

Team & Environment

You will be in a hands-on leadership role with cross-functional exposure and impact, collaborating closely with R&D, regulatory, clinical, and operations teams.

Benefits & Compensation

• Competitive salary: $85,000 - $95,000 per year.
• Fully remote role with minimal travel (~10%).
• Opportunity to work on innovative digital health and medical device projects.
• Professional growth and development in a regulated, fast-evolving industry.

Work Mode

This is a fully remote role, with the position open to candidates located in South Carolina. Travel is expected to be minimal, at approximately 10%.

Jobgether is an equal opportunity employer.