Quality Assurance Specialist II
Core
Reviewing equipment and process validations, change controls, and technical transfers for RUO and IVD TDX HLA Typing kits and reagents to ensure compliance with medical device regulations.
Role type
Quality Assurance Specialist II (Medical Device/Diagnostics)
Builds
Robust manufacturing processes, QC methods, and documentation to support Design Master Records (DMR) for HLA Typing kits.
Domain
Medical Device / In Vitro Diagnostics (IVD) / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation proficiency (IQ/OQ/PQ), Risk Assessment methodology, Knowledge of ISO and GMP regulations, Protocol and report writing, Cross-functional collaboration, Project management, Root cause analysis, Statistical methods, Process improvement.
Preferred skills
None explicitly stated as preferred.
Technologies
MS Word, Excel, PowerPoint, Computer/Automation systems.
Responsibilities
Review validation projects, protocols, and reports for equipment and process validation; Write and review protocols and reports for validation and new design processes; Assist in Risk Assessment exercises; Collaborate with R&D and Technical Operations for process development and technical transfers; Recommend approval or failure of validation studies; Maintain knowledge of Medical Device regulations; Perform data entry and provide tracing/trending reports.
Seniority
Mid-level, independent contributor with moderate guidance.
