- Cardinal Health (Tallahassee, FL)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- Stryker (Orlando, FL)
- …Analysis (sFMEA), Security Risk Assessments and defect management, software verification/ validation . **Preferred:** + Bachelor's degree in Computer Engineering, ... Medical Division. + Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance… more
- Kelly Services (Doral, FL)
- …meetings to align quality initiatives with business goals. + Host and support ** FDA inspections** and **GMP audits** . + Review and approve **batch records, ... deviations, CAPAs, change controls, and validation protocols** . + Supervise the development and maintenance...dosage forms** . + In-depth knowledge of **cGMPs** , ** FDA regulations** , and ** FDA Guidance** .… more
- University of Miami (Miami, FL)
- …Proficiency: Skilled in using office software, technology, and relevant computer applications. + Communication: Strong verbal and written communication skills ... SOPs are in compliance with relevant rules and regulations such as the FDA , CLIA, state testing requirements, Joint Commission, etc., managing FDA reportable… more
- Fujifilm (Tallahassee, FL)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …train junior colleagues; contribute to continuous improvement within the group. Comply with FDA , EPA and OSHA regulations, performing all work in a safe manner. ... FL location. **The Role** + Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water… more
- Stryker (Orlando, FL)
- …Healthcare IT or Systems Engineering **Preferred:** + Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer ... Security Risk Assessments and defect management, software testing and/or verification/ validation . + Previous employment at leading technology companies such as… more
- University of Miami (Miami, FL)
- …needs of patients according to their documented physical/development requirement by competency validation checklist: + Children + Adolescents + Adults + Geriatric + ... modality including but not limited to: Joint Commission, AHCA, ACR, FL DOH and FDA /MQSA. This list of duties and responsibilities is not intended to be all-inclusive… more
- Cardinal Health (Tallahassee, FL)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more
- Medtronic (Jacksonville, FL)
- …assessment through to procedure production release including equipment installation and validation activities + Lead development of a system-based approach for ... the project lifecycle + Medical device / regulated / FDA environment + Developed and implemented culture change +...The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
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