- Danaher Corporation (Sunnyvale, CA)
- …plus if you also possess previous experience in: + Experience in biomedical or medical device manufacturing + Certified Quality Engineer and/or Lead Auditor ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Quality Engineer is responsible for driving manufacturing and product… more
- Danaher Corporation (Brea, CA)
- …would be a plus if you also possess : + Experience in FDA-regulated or medical device manufacturing environments. + Familiarity with ISO13485, 21 CFR Part 820, ... System (http://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Global Supplier Quality Engineer - Systems and Innovation for Beckman Coulter… more
- ThermoFisher Scientific (San Francisco, CA)
- …+ 5 years of experience in a regulated industry such as pharma and/or medical device manufacturing required. Preferably within a QC GMP laboratory. + Experience ... biological products etc.), Will work with hazardous/toxic materials **Job Description** **Title: Quality Control Scientist III - Cell and Gene Therapy** As part of… more
- BeOne Medicines (San Mateo, CA)
- …+ Minimum of 8+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global environment + In-depth operational experience in at ... **General Description:** The Associate Director, Digital Quality Management Systems (QMS) Operations and User Experience,...Improvement + Ensure digital QMS applications remain compliant with regulatory requirements (eg, US, EU, ICH GxP). + Work… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non- Medical device products and software + ... to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the...+ Software experience including SaMD/SiMD is a plus + Regulatory and Quality Information Management systems such… more
- Abbott (Pleasanton, CA)
- …project teams** to drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA, ISO 13485). + ... qualifications** , ensuring documentation and processes meet internal and external regulatory requirements. + **Collaborate with engineering, quality , and… more
- Actalent (Carlsbad, CA)
- … Intern, and QC. Our work environment offers impactful work in the medical device industry, career development, and comprehensive benefits including medical ... Job Title: Quality Engineer Job Description We are seeking a...review changes to products, SOPs, and other documentation for regulatory submissions. + Support supplier evaluation and qualification. Essential… more
- Abbott (Alameda, CA)
- …development is required. **Preferred Qualifications** + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA) is desirable. + ... Embedded UI design experience preferred + Detailed experience with medical device development processes and FDA 510K...device development processes and FDA 510K and PMA regulatory requirement and process is desirable. + Good knowledge… more
- Abbott (Pleasanton, CA)
- …Engineering organization. Accountable for delivering scalable, reliable, high-performance, innovative medical device software and non-regulated digital health ... engineering. Master's Degree preferred. + Software development experience required in medical device , digital health, and/or other highly regulated industry.… more
- Abbott (Santa Clara, CA)
- …meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series. **Principal ... Biocompatibility support to the research & development of new medical device products as well as the...devices and related documentation to ensure biocompatibility and appropriate Regulatory and Quality compliance. + Oversee development… more