- BD (Becton, Dickinson and Company) (Brea, CA)
- …devices marketed in all regions throughout the world. + Expertise in failure investigation and medical device CAPA process. + Experience in medical device ... field. + Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry;...working in a design center. **Knowledge and Skills:** + Quality Management Systems requirements for medical devices… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** **Key** **Responsibilities:** + Serve as a lead quality engineer for medical device combination product development ... and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO...in quality assurance for the development of medical devices and/or drug- device combination products. +… more
- Hologic (San Diego, CA)
- …or a related field, or equivalent experience. + 3-5 years of experience in post-market quality assurance within the medical device industry such as ... Quality Assurance Specialist (Post-Market) San Diego, CA, United...in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release. The ideal candidate will be… more
- 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
- Abbott (Temecula, CA)
- …writing skills. **Preferred Qualifications** + Masters Degree Preferred + Prior medical device experience preferred. ASQ CQE certification preferred. Design ... Minimum 5 years Previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA , GMP, and ISO 13485 +… more
- Abbott (Santa Clara, CA)
- …to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are ... PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. + Ability to work within a team and… 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
- Cordis (Irvine, CA)
- …Stay up-to-date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to ... by creating next-generation solutions that address unmet and critical medical needs. The **Principal Manufacturing Quality Engineer**...a related field. + At least 8 years in medical device production development + Previous experience… 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 ... + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other...ultrasound research or a PhD (preferred). + Ultrasound based medical device product development is highly preferred.… more
- Abbott (Alameda, CA)
- …development is required. **Preferred Qualifications** + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA ) is ... device preferred + Embedded UI design experience preferred + Detailed experience with medical device development processes and FDA 510K and PMA regulatory… more