- Hologic (San Diego, CA)
- …ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as ... quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485,...mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management… 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …14971). + Assess Cloud based multifunction SaMD products to determine compliance with FDA 's guidance on device versus non- device functionality. + Prepare, ... compliance, expedition of product clearances and maintain the highest quality standards. Candidates will be expected to work on-site...+ Provide training and guidance to cross-functional teams on FDA guidance for SaMD and multifunction device … more
- Stryker (San Jose, CA)
- …Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to support projects as a quality engineer for post-market activities to drive ... Quality Engineer, Post Market** to support our Medical 's Digital Health division and portfolio...strong technical skills. + Experience with Software as a Medical Device (SaMD) and Software in a… more
- Astrix Technology (Irvine, CA)
- …of FDA regulations (21 CFR 820/803), ISO 13485 + Experience with medical device complaint handling and regulatory reporting (MDR, Vigilance, etc.)This job ... leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses...drive product and process improvements + Maintain compliance with FDA , ISO 13485, and global quality standards… more
- Abbott (Alameda, CA)
- …environment such as medical devices or pharmaceutical products. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, ... serve people in more than 160 countries. **Job Title** ** Quality Engineer II** **Working at Abbott** At Abbott, you...of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer… more
- Actalent (Vista, CA)
- …reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to Competent Authority or FDA . + Review ... company. This includes the development and maintenance of the Quality Management System, obtaining FDA and ISO...auditing + Quality Management System (QMS) + Quality assurance + Medical device … more
- Abbott (Alameda, CA)
- …10 yrs of work experience will be considered. + Min 10 years of experience in the medical device industry + Min 8 years auditing per ISO and/or FDA ... of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000...audits to assess compliance to the requirements of the quality system, as well as FDA , ISO,… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Assurance, you are responsible for: **Job** **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 Part 4,...in quality assurance for the development of medical devices and/or drug- device combination products. **Preferred… more