Senior Scientist QA Operations
Core
Ensure compliance with quality standards and regulatory requirements across manufacturing operations, lead investigations, and implement corrective actions to maintain product quality.
Role type
Quality Engineer II (QA Operations)
Builds
Critical medical devices, pharmaceuticals, or biotechnology products
Domain
Life Sciences / Medical Devices / Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/ISO regulated environment experience, risk management, root cause analysis, CAPA, change control, internal audits, regulatory inspection support, statistical analysis, quality management software proficiency, technical writing
Preferred skills
ISO 13485/FDA Lead Auditor certification, ASQ certification (CQE, CQA), clean room environment experience, foreign language skills
Technologies
TrackWise, SAP QM
Responsibilities
Ensure compliance with quality standards and regulatory requirements, collaborate with cross-functional teams to drive continuous improvement, lead investigations and implement corrective actions, conduct internal audits and support external regulatory inspections, develop SOPs, protocols and reports
Seniority
Mid-level, hands-on IC
