Change Control and Quality Systems Specialist
Core
Ensuring quality and compliance within regulated environments while supporting continuous improvement and operational excellence across quality systems.
Role type
Quality Systems Specialist (Medical Device)
Builds
Quality management systems, compliance documentation, and audit readiness for medical device operations.
Domain
Life Sciences / Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GxP regulations knowledge, ISO standards (9001/13485) expertise, CAPA and deviation management, change control processes, internal/external audit execution, SOP authoring, statistical analysis, quality metrics reporting, quality systems software proficiency (TrackWise, KNEAT), risk assessment methodologies, continuous improvement tools.
Preferred skills
Medical device change management experience, project management experience, Life Sciences/Engineering/Chemistry/Biology/Validation background.
Responsibilities
Manage and support quality systems including CAPA, deviations, and change control; Ensure compliance with GMP/GxP regulations and ISO standards; Conduct and support internal and external audits; Develop and maintain quality documentation such as SOPs; Analyze data and report on quality metrics; Collaborate with cross-functional teams to drive improvements.
Seniority
Mid-level, hands-on IC