- Abbott (Alameda, CA)
- …Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and ... into their system. + Completes SWQA tasks in accordance with current Quality System Requirements. + Works independently with objectives given by SWQA Manager.… more
- Astrix Technology (Irvine, CA)
- …cross-functional teams to drive product and process improvements + Maintain compliance with FDA , ISO 13485, and global quality standards + Assist with ... ** Quality Operations Specialist** Engineering Irvine, CA, US Pay...+ Proficient in Microsoft Excel **Preferred:** + Knowledge of FDA regulations (21 CFR 820/803), ISO 13485 + Experience… more
- Abbott (Alameda, CA)
- …Our 114,000 colleagues serve people in more than 160 countries. **Sr. Specialist Quality Assurance** **Working at Abbott** At Abbott, you can do work that matters, ... and scientists. **What You'll Work On** The Sr. Specialist Quality Assurance will be responsible for training, oversight and...investigations in a regulated environment and knowledge of the FDA /QSR regulation and ISO 13485 standard is required. +… more
- Danaher Corporation (Sunnyvale, CA)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Quality Systems Specialist III is responsible for ... to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous and rigorous assessment to identify… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves ... to ensure regulatory compliance, expedition of product clearances and maintain the highest quality standards. Candidates will be expected to work on-site 4 days per… more
- US Foods (Hawthorne, CA)
- …Join Our Community of Food People! BASIC PURPOSE Improve product quality and consistency by conducting checks at receiving, processing and shipping. ... activities in the plant. Monitor implementation all Food safety, Regulatory and Quality programs within the assigned area of responsibility **Stock Yards -… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- **Job Description Summary** Fulfill FDA , ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to ... for Medical Device Reporting (MDR) + Prepare and submit MDR reports to FDA + Identify problems and lead projects to improve processes, procedures, and/or practices;… more
- Sysco (Fremont, CA)
- …**Education** + Formal job training in TQM principles, SPC, HACCP concepts, CFIA/ FDA regulations would be beneficial. + Formal quality and sensory ... **JOB SUMMARY** Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and… more
- J&J Family of Companies (Santa Clara, CA)
- …**Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** ... Description:** Johnson & Johnson is hiring for a **Sr. Quality Engineer - Shockwave Medica** l to join our...of principles and practices of related specialties. Familiarity with FDA guidance documents and ISO and + ASTM standards… more
- Actalent (Irvine, CA)
- Design Assurance Quality Engineer Job Summary This position is responsible for supporting electrode product and process sustaining activities through the application ... of Quality engineering skills for medical devices. Focuses on process,...of EN ISO 13485, ISO 14971, IEC 62304 and FDA QSR for Medical Devices + Ability to work… more