- Aerotek (San Diego, CA)
- …in quality assurance, packaging, and inspection. + Familiarity with DHR and computer operations. **Additional Skills & Qualifications** + At least two years of ... coagulation-based manufacturing processes. + Familiarity with GDP, GMP, GLP, FDA , and ISO standards. + Knowledge of qualification and..., and ISO standards. + Knowledge of qualification and validation trials is a plus. + Working knowledge of… more
- Medtronic (Los Angeles, CA)
- …phases of the product development lifecycle, from feasibility and design to validation , launch, and post-market support. + Develop and maintain comprehensive project ... + Ensure compliance with internal and external regulatory requirements (eg, FDA , ISO) throughout the project. + Drive continuous process improvement initiatives… more
- Medtronic (Northridge, CA)
- …of ISO 10993 and global medical device regulations (eg, EU MDR, FDA , REACH, Prop 65). + Experience with biocompatibility assessments, toxicological risk evaluation, ... testing. + Knowledge of design control, risk management, and design verification/ validation processes. + Strong technical writing, data analysis, and statistical… more
- Medtronic (Santa Rosa, CA)
- …in compliance with medical device standards. + Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, and other design-controlled regulations, providing ... and interpersonal skills + Demonstrated working knowledge of process validation , statistical methods, risk management **Physical Job Requirements** The above… more
- J&J Family of Companies (Santa Clara, CA)
- …MedTech experience to support compliance activities related to ISO 13485, ISO 9001, FDA and GDPR regulations. + Partner with third party vendors, ensure timely ... **Requirements** + Bachelor's degree in Healthcare Informatics, Health Information Management, Computer Science, or related field. + Minimum of 10 years of… more
- Abbott (Milpitas, CA)
- …and ensures compliance with company policies and procedures (eg compliance with FDA regulations, etc.) + *Makes and executes operational decisions with a strategic ... degree in Human Factors Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, Mechanical Engineering or other scientific or engineering… more
- Sumitomo Pharma (Sacramento, CA)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… 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
- 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. + ... and organized design history, detailed 2D drawings and BOMs. 6. Proficient computer skills, including MS Word, Excel, Outlook, and Teams. **Desired Qualifications**… 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 ... teammates, customers, and vendors. **Required Qualifications** + Bachelor's degree in Computer Science, Engineering, or a related field, or equivalent practical… more
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