- AbbVie (Irvine, CA)
- …product launches and tech transfer. *Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products. *Assist ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class II or III devices, or ... (Design Assurance, Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated medical device knowledge… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports ... ability to operate general office machinery + Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products),… more
- Cordis (Irvine, CA)
- …up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to ... Engineering, Biomedical Engineering, or a related Engineering field. + 5+ years in medical device production development + Previous experience working in a… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... **Essential Job Functions** + Design and develop software for medical device product(s) in full compliance with...for knowing and planning activities consistent with the company's quality policy and quality objectives. + Responsible… more
- Astrix Technology (Irvine, CA)
- …Knowledge of FDA regulations (21 CFR 820/803), ISO 13485 + Experience with medical device complaint handling and regulatory reporting (MDR, Vigilance, etc.)This ... ** Quality Operations Specialist** Engineering Irvine, CA, US Pay...leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses… more
- Teradyne (Agoura Hills, CA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... innovation and delivers better business results. Opportunity Overview: As the Supplier Quality Engineer , Signal Delivery, you will be responsible for technical… more
- Abbott (Sylmar, CA)
- …field (Master's or RAC certification preferred) + 10+ years of progressive experience in Quality Assurance within the medical device or digital health ... portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital...and impact. You will develop and implement a best-in-class Quality Management System (QMS) that supports both medical… more
- Abbott (San Diego, CA)
- …(IDEs, debuggers, unit test frameworks) + Knowledge of design controls and regulations for medical device development is a plus + Understanding of quality ... visual modeling, multi-threading, formal development methodologies, and source code management + Medical device product development knowledge is a plus + Ability… more
- Abbott (Sylmar, CA)
- … Quality , Compliance, Engineering, within a regulated environment, such as medical device , diagnostics or pharmaceutical industries, to develop the competence ... and follow-up skills, as well as attention to detail. **Preferred Qualifications** + Medical device experience preferred. + Knowledge of Cybersecurity and Data… more