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...
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 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...
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 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: Provides SAS programming support to all clinical studies. Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables. Provide statistical programming support for regulatory su...
Roles & Responsibilities: 5+years experience. US Project management experience. Preferable with experiences on Medical devices: Operations, Manufacturing, Supply chain experiences (diverse profiles to be chosen from). Ideal candi...
Job Summary: The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+principles and regulatory standards such as 21 CFR P...
Roles & Responsibilities: 5+years experience. US Project management experience. Preferable with experiences on Medical devices: Operations, Manufacturing, Supply chain experiences (diverse profiles to be chosen from). Ideal candi...