Roles & Requirements: 5+ Years' experience in medical device V&V for a large company. Experience with FDA-regulated V&V. IEC 62304 experience. Meaningful direct experience in writing verification protocols, executing protocols, and...
Job Description: Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and drivin...
Responsibilities: Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. Bachelor of Engineering / Diploma' in Mechanical or equivalent. Knowledge of Design History file, Device History Record and Device Master Re...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cr...
Job Description: Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and drivin...
Responsibilities: Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. Knowledge of Design History file, Device History Record and Device Master Record documents. Proficiency in Project management and execution....
Responsibilities: Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Support database setup activities including edit check specifications and user acceptance testing...
Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulation...