Responsibilities and Requirements: 7+ Years of experience in the medical device industry. Well-rounded quality engineering background with a strength in risk management. R&D, risk management, and design control quality experience. ...
Responsibilities: Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies. Interact and manage relationships with other functional areas to ensure high quality data management activit...
Responsibilities Implement and maintain the effectiveness of the quality system. Support day-to-day manufacturing and operations activities related to change control. Provide consultation and advice to regulatory specialists regarding c...
Responsibilities and Requirements: Engineering, Technical, or Scientific discipline with minimum of 4-8 years of related experience is required, preferably within a regulated environment (e.g., FDA regulated). Good Experience in IQ / OQ ...
established processes throughout the life cycle of the study, including startup, conduct and close phases. The Lead Clinical Data...
Responsibilities and Requirements: We have a requirement in our team for a Mechanical engineer with good knowledge in CAD or solid works for creating 3D layout of the existing lab infrastructure and creating the layout of the rack and the...
Responsibilities: The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/i...
Responsibilities and Requirements: Our client is Medical Device organization seeking an IT Manager who is a Polariton technical expert, understands Quality Systems Management Development from an IT perspective, and has experience working ...
Responsibilities and Requirements: Must Have Technical/Functional Skills- experience Required. Knowledge of Medical procedure and corresponding Medical Equipment. Good experience in CAPA execution, CAPA write up. Good experience in Tes...
Responsibilities: Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs. Capacity for independent programming and review of...