- Medtronic (San Diego, CA)
- …customers (Spine Surgeons) to improve designs. + Understands verification and validation activities, ensuring products meet user needs, system requirements, and ... with technology developments in specialized area + Experience working in an FDA regulated and/or medical device environment with ISO and Quality System Regulation… more
- Abbott (Alameda, CA)
- …design development, usability testing, interaction design and usability validation . Responsible for usability initiatives across product/organizational lines, and ... usability conceptual design development, usability research, interaction design, and usability validation on prototypes as well as finished product. *Organizes and… more
- Cordis (Irvine, CA)
- …* Draft design of a workspace, including materials and equipment, using computer drafting programs. * Update risk documents (FMEA's) and Quality Control Plans ... for New Product Introduction. * Verification/ Validation of processes, machines, and equipment to meet requirements.../Verification process, Gage R&R, and a clear understanding of FDA 's QSR and GMP * Working knowledge of process… more
- Cordis (Irvine, CA)
- …+ Develop, and qualify new tooling and equipment. + Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. ... + Ability to make independent decisions + Knowledge of Validation verification process, Gage R&R, and a clear understanding...verification process, Gage R&R, and a clear understanding of FDA 's QSR and GMP + Proficiency in Solid works… more
- Amgen (South San Francisco, CA)
- …degree** OR Master's degree and 2 years of Life Sciences, Bioinformatics, Computer Science, Information Systems, or related field experience **Or** Bachelor's degree ... and 4 years of Life Sciences, Bioinformatics, Computer Science, Information Systems, or related field experience **Or** Associate's degree and 8 years of Life… more
- Cardinal Health (Sacramento, CA)
- …meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and ... standards, principles, and techniques utilized within the Quality Assurance field + FDA regulated industry experience as well as applicable Quality System Standards… more
- Teleflex (Pleasanton, CA)
- …test methods for early-stage characterization and later-stage design verification & validation . * Collaborate with internal departments and external vendors to ... Experience Requirements** * Bachelor's degree in Mechatronics Engineering, Electrical Engineering, Computer Engineering, Computer Science or related field. OR… more
- BeOne Medicines (San Mateo, CA)
- …of staff in support of clinical trials, ad-hoc analysis requests, data validation , etc. in accordance with all relevant statistical regulatory guidance and ... and follow specifications to create SDTM and ADaM datasets (as needed) + Computer programming using SAS + Fundamentals of project planning and management + Drug… more
- Terumo Neuro (Aliso Viejo, CA)
- …Provide guidance and support for software user acceptance testing and software validation efforts through the creation of test protocols, reports, and other ... Name:** 100-General and Administrative **Qualifications:** 1. Bachelor's degree in Computer Science, Information Systems Management, Business, or Engineering, or… more
- LEMO Group (Rohnert Park, CA)
- …active lead in design for Manufacturability / Assembly Responsible for tool & process validation (PPAP), DQ, IQ, OQ, PQ. + Perform PFMEA Risk Analyses when required ... + Familiarity with IPC 610/620 standards, ISO 9001, ISO 13485, FDA Physical Job RequirementsQualifications/Skills: + Typical Working Conditions: Office environment,… more
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