QA Specialist
Core
Implementing and maintaining Quality Systems for medical device products, ensuring safety and efficacy through documentation, vendor evaluation, and testing.
Role type
Quality Assurance Specialist (Medical Devices)
Builds
Device Master Records, product specifications, design control files, and quality documentation for Medline brand and private label SKUs.
Domain
Healthcare / Medical Devices / Quality Management Systems (GMP/QMS)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP and QMS principles, technical file preparation for medical devices, laboratory testing protocols (e.g., USP methods), complaint investigation and trend analysis, CAPA and SCAR management, risk management, design control activities, vendor qualification, process validation and inspection review.
Preferred skills
Post-graduate diploma in QARA, ASQ professional quality certifications, SAP proficiency.
Technologies
SAP, Word, Excel, PC software applications
Responsibilities
Create and maintain Device Master Records (DMRs) and product specifications; obtain evidence and certificates to support product safety and efficacy; initiate and lead vendor qualifications; arrange laboratory testing; review methods and procedures for process control and validation; assist with complaint investigations and lead corrective actions; collaborate with suppliers on quality problems and improvement programs; provide quality expertise in Product Development and Design Control.
Seniority
Mid-level, hands-on IC
