Summary : We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualifica...
, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...
Job Description This person is going to be helping design an assembly line - calculating Demand at Capacity, building excel files to calculate # of stations needed, reviewing OMS/work content to potentially combine work stations, manipulat...
Roles & Responsibilities : Provide day-to-day technical support for serialization systems (vision systems, printers, scanners, PLCs) in 247 support environment. Troubleshoot and resolve serialization-related issues on packaging lines. E...
, including packaging integrity, shelf life, and transit testing. Good documentation practice skills. Good verbal and oral...
Job Description: Quality Control (QC) of in-house components: Develop inspection protocols, control charts, validate measurement equipment. New Product Introductions & Corrective Actions: Lead cross-functional teams, troubleshoot manufactu...
Job Description: The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individu...
Roles & Responsibilities : Perform routine & specialized laboratory testing following GMP/cGMP guidelines Experience with instrument calibration, qualification & basic troubleshooting Prepare reagents and manage lab inventory & supplies...
Responsibilities: Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expec...
Job Summary: Support quality engineering initiatives across supplier quality, manufacturing, and quality systems. Ensure products meet regulatory, customer, and internal quality requirements through effective process controls, CAPA execu...