Diego Ramirez Email & Phone Number

Lawrence Township, NJ, US

Lawrence Township, NJ, US

Lawrence Township, NJ, US

• I implemented, supported and monitored the effectiveness of the Quality Systems and Training within the Global External Manufacturing (ExM) organization, focused on Document Control and ManagementMy accomplishments.
• Act as end-to-end local process owner of the ExM Document Management System (DCA).
• Own all elements of the process including relevant procedures / forms training materials and metrics.
• Ensure all elements of the process are compliant with Regulatory, Health Authority and BMS requirements, policies and procedures.
• Act as the interim ExM main point of contact and assessor for the implementation of the global electronic Documentation Management System, BMSDocs

Ocala, Florida, US

• I engage with regulatory, manufacturing, QA, and QC liaisons to build dossier components. I also play a key role in ensuring the quality of manufactured products complies with all applicable regulations and.
• Evaluate all documents to ensure compliance to Current Good Manufacturing Practices (cGMP) while providing monthly compliance metrics to management.
• Perform internal and external audit of the contract services and support manufacturing and quality control department
• Charged with managing and ensuring implementation of process changes, compliance and / or execution of timelines and quality deliverables.

Ocala, Florida, US

Ocala, Florida, US

• I collaborated with QA team to accomplish the regulatory / QA objectives of the organization, monitored performance of the quality system, and interacted with research, manufacturing, and QC departments to assure cGMP.
• Composed, reviewed, and approved cGMP required documentation, and assessed / audited raw material suppliers.
• Managed raw material release and supply for manufacturing while overseeing release of raw intermediates and finished drug products.
• Recognized for examining or reviewing investigation reports for deviations, conducting cGMP training, and reviewing / tracking CAPAs to completion.
• Implemented risk analysis during audits, investigations and to 21 CFR part 11 systems; participated in audits to suppliers of raw material and services.
• Executed internal audits to the different departments and managed cGMP documentation through their life cycle.

Didam, Gelderland, NL

• I executed R&D tasks and provided service and engineering support to the sales area of the company. In this role, I also developed and implemented assistive technology for people with disabilities and enhanced /.
• Directed projects including assembly, product safety, testing, end-user training, and after sales services of devices developed and / or distributed by the company.
• Managed and maintained regulatory liaisons for assistive devices developed and distributed by the organization.
• Oversaw FDA requirements for marketing and distribution of assistive devices, 21 CFR Part 820.
• Assured compliance with registration and listing of devices in the FDA database and coordinate / recorded the required documentation for 510K pre-market notification of applicable devices.

Newark, NJ, US

• I developed and implemented assistive technology focused in the rehabilitation process of children with physical impairments. I successfully integrated admittance-controlled haptic robots with virtual environments that.
• Applied simple statistical tools to analyze results of experiments and validity of the initial postulates and hypotheses.
• Arranged data and support documentation to submit research projects to different scientific journals for publication.
• Created interfaces to control in real time a commercially available robotic manipulator, which was installed in a wheelchair used for children with orthopedic disabilities.
• Devised 3D virtual models of a six-degree-of-freedom robotic manipulator using VRML-based software including the required kinematics computation.

Newark, NJ, US

New York, New York, US

• I developed and implemented assistive technology focused in the rehabilitation process of children with physical impairments. I successfully integrated admittance-controlled haptic robots with virtual environments that.
• Applied simple statistical tools to analyze results of experiments and validity of the initial postulates and hypotheses.
• Arranged data and support documentation to submit research projects to different scientific journals for publication.
• Created interfaces to control in real time a commercially available robotic manipulator, which was installed in a wheelchair used for children with orthopedic disabilities.
• Devised 3D virtual models of a six-degree-of-freedom robotic manipulator using VRML-based software including the required kinematics computation.

New York, New York, US

I tested, documented and reported IQ, OQ and PQ of the pharmaceutical plant manufacturing equipment and the quality control instruments.Responsible for creation of protocols for tests and verifications carried out in the equipments of the plant and quality control laboratory.Design of test protocols (IQ, OQ, PQ).Execution of specific tests according to.

Master Of Science (Ms), Biomedical/Medical Engineering

Bachelor'S Degree, Electrical And Electronics Engineering