- J&J Family of Companies (Santa Clara, CA)
- …product development lifecycle including design, implementation, debug, verification & validation , qualification, and transfer to manufacturing. + Experience and ... PDM and/or Agile EC. + Experience with designing hardware products in an FDA or other regulated industry; comfortable with concepts of design input, design output,… more
- Terumo Neuro (Aliso Viejo, CA)
- …Develop test plans, protocols, and reports as part of design verification and validation . + Develop designs that are robust and optimized for manufacturability. + ... spatial packaging of components. 7. Working knowledge of medical devices and FDA regulations. 8. Experience with CAPA systems, including complaint handling. 9.… more
- Eliassen Group (Sacramento, CA)
- …main focal point for the component system, including data collection, data validation , meeting coordination, rollout execution, and progress updates + Perform risk ... actions + Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components **Experience Requirements:** + Ability to… more
- J&J Family of Companies (Santa Clara, CA)
- …product development lifecycle including design, implementation, debug, verification & validation , qualification, and transfer to manufacturing. + Proven experience ... medical capital equipment. + Experience working in an ISO and FDA regulated environment. The Company maintains highly competitive, performance-based compensation… more
- Kelly Services (Sunnyvale, CA)
- …technical dossiers and approval licenses, including but not limited to software validation and data entry + The Regulatory Affairs Process Specialist will review ... to EU notified body or rest of world health authorities. + Update FDA establishment registrations and device listings for IVD products. + Maintain and administrate… more
- J&J Family of Companies (Santa Clara, CA)
- …for existing products. + Support the transfer of product lines and the qualification- validation efforts. + Other duties as assigned. These job requirements are not ... of and compliance with applicable Quality System requirements such as QSRs, FDA , ISO, MDD and other applicable regulations. + Experience and understanding Process… more
- Abbott (Alameda, CA)
- …is always "audit ready" (project team training records, central files, system validation , etc.). + If applicable, ensures adequate monitoring is conducted on all ... compliance guidelines for clinical trials (eg applicable ISO Standards, FDA ). Strong problem-solving skills. + Strong computer skills. Demonstrated ability… more
- JBS USA (Manteca, CA)
- …and prerequisite program requirements. This position will ensure compliance to USDA/ FDA guidelines for food safety/SQF and BRC requirements. Also responsible for ... all packaging, LOG's, and other validations + Be capable of doing swabs and validation tests as needed + Have the ability to perform Pre-shipment reviews, recalls,… more
- Abbott (Sylmar, CA)
- …QA, and regulatory teams to ensure our systems are fast, reliable, and compliant with FDA and ISO standards. **What You'll Work On** As a DevOps Engineer 2 working ... in the medical device or healthcare space. + Knowledge of software validation , design history files (DHF), and change control processes. + Strong documentation… 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