- Amazon (Sunnyvale, CA)
- …to international expansion and certification strategies. - Oversee all aspects of hardware compliance for a device when required. - Stay abreast of industry ... and Echo. What will you help us create? The Role: Hardware safety compliance engineers are responsible for ensuring the company's products meet all relevant safety… 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 ... Science, Chemical or Biomedical/Bioengineering) with a minimum of 5 years' experience in medical device engineering or a master's degree in engineering and 3+… more
- US Tech Solutions (San Bruno, CA)
- …Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1. Support the creation ... and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in software… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...working with Marketing teams to provide regulatory strategy and compliance input. + Assist with promotional content development and… 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 ... with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21...ISO and + ASTM standards related to quality and medical device industry. + Independently assesses if… more
- Abbott (Alameda, CA)
- …discipline. + Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR ... of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000...+ Ensures Device History File (DHF) and Device Master Record (DMR) are in compliance … more
- Caldera Medical (Westlake Village, CA)
- …and regulatory requirements. * Ensure timely and accurate complaint evaluations, including medical device reporting (MDR) or equivalent regulatory submissions. * ... complaints and working on CAPA. * Bachelor's degree preferred. * Experience working within medical device industry and familiarity with 21 CFR 820, and ISO 13485… more
- Abbott (Santa Clara, CA)
- …by providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... Assists management and leadership on regulatory activities and works with the medical device business units that Leverage Services team supports, including… more
- Terumo Medical Corporation (San Francisco, CA)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes...degree and a minimum of 3 years experience in Medical Device Sales with Cath Lab and/or… more
- ZOLL Medical Corporation (San Jose, CA)
- …+ Provide ongoing education and training to hospital and office staff on medical device order requirements and workflows to achieve operational efficiencies. + ... university or equivalent combination of education and experience in sales. + Healthcare/ Medical Device (Clinical or Billing) experience preferred + Experienced… more