Responsibilities : Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle). Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ...
Responsibilities : Oversight and leadership of the non-conforming product, deviation, and MRB processes. Review/approve Device History Records, Nonconformances, Deviation, and other product related records. Review/approve routine facili...
Responsibilities : Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings. Responsible for the study-specific data management tasks from protocol review to database lock to e...
Responsibilities and Requirements: Apply mechanical engineering theoretical principles and techniques to understand how products come together with the intent of improving equipment reliability. Collaborate with cross-functional team mem...
Responsibilities Assists with the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Assists in protocol writing, obtaining the required institu...
Responsibilities: Bachelor's degree (B.S.) in related field or equivalent. Five year's related experience or equivalent in a Medical Device or FDA Regulated industry. Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, ...
Responsibilities and Requirements: Minimum master's degree in health economics, Biostatistics, Health Services Research, Public Health, Epidemiology, Pharmacy Administration, or other relevant discipline, with experience in coding and dev...
Responsibilities: Provide QA support on the floor for production. Ensure process control measures are in place and followed in product manufacturing. Receipt and disposition of incoming apheresis material. Oversee and authorize shipmen...
Responsibilities: Lead and support the verification and validation strategy for medical device projects in an FDA-regulated environment. Ensure V&V activities comply with internal quality requirements and relevant regulatory standards (I...
Responsibilities and Requirements: 5+ yrs testing/validation experience with LS background. Strong knowledge/experience with LIMS (Laboratory Information Management System), Sitara / LIMS Instrument Integration. Good understanding ...