Sr. Quality System Engineer
Core
Senior professional individual contributor leading complex Quality Management System (QMS) compliance initiatives, policy implementation, risk assessments, and audit readiness for medical device operations.
Role type
Senior IC Quality System Engineer (Medical Devices)
Builds
QMS compliance frameworks, risk mitigation plans, and audit-ready documentation for medical device sites and business units.
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS compliance, risk-based thinking, regulatory change implementation, technical writing, project leadership, cross-functional alignment, process standardization, Good Documentation Practices, remediation management, audit support
Preferred skills
Leading multi-site QMS deployment, compliance technology implementation, mentoring junior staff, executive-level reporting
Technologies
Compliance technology platforms, digital workflow tools
Responsibilities
Lead complex QMS compliance projects and risk assessments; define implementation approaches and governance; provide senior-level review of QMS changes and procedures; lead cross-functional meetings to align stakeholders; mentor junior specialists; support regulatory inspections and notified body audits; drive process standardization and continuous improvement.
Seniority
Senior, hands-on IC with strategic alignment
