- BD (Becton, Dickinson and Company) (Brea, CA)
- …life sciences related field. + Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and ... of 21CFR, MDD 93/42/EEC, MDR 2017/745, ISO13485, and ISO14971 + Quality system auditing + Management of FDA and notified body audits. + Risk Management + Change… more
- Astrix Technology (Irvine, CA)
- …(eg MDRs, Vigilance reports, etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and ... ** Quality Operations Specialist I** Manufacturing Irvine, CA, US...and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies pertaining… more
- Actalent (Vista, CA)
- …aspects of the company. This includes the development and maintenance of the Quality Management System, obtaining FDA and ISO certifications, and product ... of high- quality supplements, annual reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to Competent… more
- J&J Family of Companies (Santa Clara, CA)
- …systems being developed + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned ... developments related to company's products + Interface with R&D, Regulatory, Quality , IT and other cross-functional stakeholders to ensure acoustic lab operations… more
- ManpowerGroup (Fremont, CA)
- …years of medical device quality assurance experience. + In-depth knowledge of quality management systems (ISO, FDA , IVDR, QSR). + Proven experience in ... client, a leader in the healthcare industry, is seeking a Quality Engineer III to join their team. As a Quality Engineer III, you will be part of the Quality… more
- J&J Family of Companies (Santa Clara, CA)
- …products being developed + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned ... processes by working closely with research/development, operations, regulatory, and quality teams. **Essential Job Functions** + Develop product(s) for manufacturing… more
- Element Materials Technology (Santa Fe Springs, CA)
- …experiments and observations + Assist in audit preparedness and for participating in quality audits with FDA , other Regulatory Agencies, and customers, as needed ... II** is responsible for performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in...federal regulations, including but not limited to GMP, DEA, FDA , etc. **Skills / Qualifications** + Requires a minimum… more
- J&J Family of Companies (Santa Clara, CA)
- …and assembly documentation + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned ... in full compliance with the company's Design Control requirements and consistent with FDA , ISO, and MDD/MDR requirements + Prototype and develop proof of concept… more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …and maintain a mindset of continuous improvement. + Work within the company's corporate quality system and ISO/ FDA regulations to remain compliant. + Develop and ... for developing an optimal organization and team to achieve safety, quality , delivery, inventory, and productivity targets while being compliant with local… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure ... (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within the Western desert… more