Job Description: Responsibility for the Quality and Compliance of process development and manufacturing of implantable ( Class III) Cardiac and Neuromodulation medical device related products. Initial scope of work may be focused on Inspec...
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 Summary: Quality Engineer responsible for supporting manufacturing operations by managing nonconformances and CAPA activities, assisting inspection teams, and conducting investigations related to field corrective actions and risk eval...
Job Description: The CSV Engineer will serve as an individual contributor responsible for ensuring compliance with industry regulations and standards while driving efficiency in site and process improvement projects. This role requires exp...
Job Summary: The CSV Engineer will be responsible for validating ERP, SAP, and MES manufacturing applications in a regulated environment. The role involves ensuring compliance with GxP standards through risk-based validation, supporting...
Job Description: The Contract Lead Programmer serves as a senior, hands-on programmer responsible for managing statistical programming activities across multiple clinical trials and therapeutic areas. The role oversees external CRO partner...
Responsibilities: Supplier Monitoring: Perform supplier oversight and product inspections for regular project execution to ensure compliance with specification. Inspection types include visual, dimensional, weld, coating, traceability, qu...
Roles & Responsibilities: Lead or support complaint investigations and resolution related to packaging. Support engineering in product validation, risk assessments, product/process development, and change management. Support and lead co...
Job Description: Material Handler II is responsible for the safe, accurate loading and unloading of product within the distribution center. The following duties and responsibilities are intended to be representative of the work performed b...
Job Summary : The Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equip...