Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class...
Job Description: The MRP Planner ensures smooth material flow to support manufacturing operations. This role focuses on supply planning, inventory control, and cross-functional coordination using SAP ECC. It requires strong analytical skil...
Job Description: Responsible for manufacturing and assembling clinical and commercial products. Operates production equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantiti...
Roles & Responsibilities: Plan, develop, and implement QA standards, inspection, and testing procedures. Support manufacturing operations to ensure product quality and compliance. Lead failure investigations, root cause analysis, and CA...
Job Description: We are seeking a skilled Electrical Engineer (PCB Design) to join our engineering team in Holyoke, MA. In this role, you will be responsible for the end-to-end design and development of multilayer printed circuit boards (P...
Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities f...
Responsibilities: Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the develop...
Responsibilities: Lead and manage reliability improvement projects within operations and engineering. Author and review Change Control and Quality documents related to product or process modifications. Maintain operational compliance wi...
Responsibilities: Serve as the technical SME for qualification of analytical equipment in manufacturing setup. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 1...
Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert...