- Stryker (Irvine, CA)
- …with incoming, in-process, and finished product inspections, including product validation testing. **Workplace Flexibility:** **2nd Shift (Onsite Role):** This ... implementing, and maintaining the Quality Management System in compliance with FDA Quality System Regulation, ISO 13485, and other applicable standards. +… more
- Terumo Neuro (Aliso Viejo, CA)
- …path. 6. Familiarity of software testing methods, including principles of formal computer software validation (CSV). Knowledge of medical device software ... **Department Name:** 105-Information Technology **Qualifications:** 1. Bachelor's degree in computer science, Information Systems Management, Business, Engineering, or related… more
- Cardinal Health (Sacramento, CA)
- …(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 (Irvine, CA)
- …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
- Sumitomo Pharma (Sacramento, CA)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Amgen (Thousand Oaks, CA)
- …Global Facilities and Equipment Maintenance and Calibration program applying CMMS ( Computer Maintenance Management System). You will possess the ability to interact ... EAM, or equivalent). + Ensure secure data management, system validation , and electronic record compliance per 21 CFR Part..., and **statistical analysis** . + Strong understanding of ** FDA ** , **GMP** , **ISO 9001** , and **ISO/IEC… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …to conduct clinical trials and publish scientific articles. + Conduct verification and validation testing in accordance with FDA and ISO standards, support ... of possible** with us. **Requires Skills/Experience:** + PhD degree in Computer Science, Electrical Engineering, Machine Learning, Physics, or a closely related… more
- Sumitomo Pharma (Sacramento, CA)
- …undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. + Work closely with ... to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge...communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America… more