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QA/RA Project Manager at Jobgether. This position is posted by Jobgether on behalf of DeepHealth. We are currently looking for a QA/RA Project Manager in South Carolina.. This role is ideal for a detail-oriented and strategic professional who thrives at the intersection of quality assurance, regulatory compliance, and project management. The QA/RA Project Manager will oversee quality and regulatory activities across the product development lifecycle, ensuring medical device software and digital health solutions meet the highest standards of safety, performance, and compliance. The position requires cross-functional collaboration with R&D, regulatory, clinical, and operations teams. You will lead QARA workstreams, manage risks and issues, implement continuous improvement initiatives, and provide clear reporting to executive stakeholders. This is a hands-on position where your work directly impacts product quality, regulatory readiness, and operational excellence.. Accountabilities. ·         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 (FDA 510(k), CE Mark, etc.).. ·         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.. ·         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.. ·         Proficiency in tools like SmartSheet, Jira, or Ketryx preferred.. ·         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.. Company Location: United States.