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...
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: The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects, ensuring ...
Job Description: Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+principles and regulatory standards (21 CFR Part 11, Annex 11). Review audit trails, monitor user acces...
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...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...
Responsibilities: This role involves reading and interpreting wiring diagrams, as well as troubleshooting electrical systems on vehicles. The position requires custom designing for client orders, which may vary from straightforward to co...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: 1. Testing and Validation: Plan and conduct functional tests and performance evaluations on hardware prototypes. Identify and troubleshoot issues related to hardware functionality and compatibility. Collaborate with so...
Job Description: We are looking for a Project Manager with a strong understanding or prior experience in Packaging Technology to lead projects focused on cost savings, sustenance, and Value Engineering / Value Analysis (VE/VA). This role c...