Specialist Quality Assurance
Core
Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions and controlling manufacturing processes.
Role type
Specialist, Quality Assurance (Manufacturing)
Builds
Manufacturing processes and quality compliance for medical devices
Domain
Healthcare / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Knowledge of cGMPs and CFRs, data analysis, root cause analysis, statistical process control, equipment maintenance, procedure writing
Preferred skills
Industry experience, supervisory experience, operations exposure
Technologies
Computer software programs
Responsibilities
Perform returned goods analysis and enter data for post-market surveillance, assist engineering in identifying manufacturing issues and implementing corrective actions, train operators on basic processes and engineering changes, support process development during new product introduction, collect and compile data for qualification and validation studies
Seniority
Specialist, individual contributor
