- Stryker (San Jose, CA)
- …of applicable domestic and international regulations and quality system standards - FDA QSR, MDD, ISO13485, ISO9001, etc. + Experience in independently executing ... moderately complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design. + Solid analytical skills, ability to plan, organize and implement concurrent tasks. +… more
- Fortive Corporation (Irvine, CA)
- …maintenance, building utilities, or related technician role in a GMP, FDA -regulated, or cleanroom environment. + Experience maintaining and troubleshooting critical ... building utilities and facility infrastructure. **Education** + High School Diploma or Equivalent required. + Associate's Degree in HVAC, Mechanical, Electrical Technology or a related field preferred. + Equivalent combination of education and experience will… more
- Danaher Corporation (Brea, CA)
- …It would be a plus if you also possess : + Experience in FDA -regulated or medical device manufacturing environments. + Certifications such as CQE, CQA, Six Sigma, ... or equivalent. + Familiarity with ISO13485, 21 CFR Part 820, and other relevant regulatory frameworks. The salary range for this role is $130,000-$160,000 USD range. This is the range that we in good faith believe is the range of possible compensation for this… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …as a trainer or facilitator + Experience in a regulatory environment ( FDA /ICH) or field within Healthcare, Life Science or Diagnostics. + MBA preferred. ... **_Location_** + This is an office-based hybrid role in any of the following locations: + San Diego, CA (preferred) + Durham, NC + Franklin Lakes, NJ + Monday, Tuesday, Wednesday, and Thursday are required in-office days each week. + Travel up to 50%, with… more
- University of Southern California (Los Angeles, CA)
- …and we have become a trusted resource for Congress, federal agencies (including CMS, FDA , CBO, and NIH), and organizations such as the National Academies of Science, ... Engineering, and Medicine. In 2023, Schaeffer-affiliated faculty testified before the Senate Commerce, Science and Transportation Committee; the Senate Finance Committee; and the House Ways & Means Subcommittee on Health. Center experts are regularly sought… more
- Edwards Lifesciences (Irvine, CA)
- …in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation. + Effective communication and ... interpersonal skills. + Proven expertise in usage of MS Office Suite. + Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management. + Problem-solving, organizational, analytical, and critical… more
- Medtronic (Northridge, CA)
- …of ISO 10993 and global medical device regulations (eg, EU MDR, FDA , REACH, Prop 65). + Experience with biocompatibility assessments, toxicological risk evaluation, ... and material characterization. + Experience with analytical techniques (eg, LC, GC, MS) and drug compatibility testing. + Knowledge of design control, risk management, and design verification/validation processes. + Strong technical writing, data analysis, and… more
- Globus Medical, Inc. (San Diego, CA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... individual will work with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions. **Essential Functions:** + Designing and developing instruments and implants using Pro/E software + Working with in-house… more
- Fujifilm (Santa Ana, CA)
- …years of inventory control/ cycle count experience. + Experience in ISO and FDA regulated businesses, and cGMP environment a plus. + Ability to perform arithmetic ... (eg, add, subtract, divide and multiply) routinely. + Knowledge of the metric system. + Operate sit-down and stand-up forklift. + Knowledge of cycle count process. + Knowledge of ERP systems and RF scan guns. + Knowledge of Good Manufacturing Practices (GMPs).… more
- Cardinal Health (Sacramento, CA)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). * Draft, ... negotiate and review a wide range of agreements, including complex matters relating to manufacturer supply agreements and co-marketing arrangements. * Advise and ensure that internal clients receive sound, practical and timely legal advice on a wide variety of… more