- Abbott (Temecula, CA)
- …metal stents, guide wires, balloon dilatation catheters, imaging catheters and software , vessel closure devices and peripheral stents. Our location in **TEMECULA, ... to meet daily production schedules while enhancing productivity and product quality . **_MAIN RESPONSIBILITIES_** + Manage projects which include new production… more
- Kratos Defense & Security Solutions, Inc. (San Jose, CA)
- …the entire document lifecycle from drafting to final distribution, including quality control and adherence to established procedures. Responsible for creating ... Ensure that all documentation complies with regulatory, legal, and quality requirements.* Collaborate with cross-functional teams to ensure that documents… more
- J&J Family of Companies (Santa Clara, CA)
- …of experience with a Master's Degree. + Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA , ISO, MDD and other applicable ... for setting up, operating, and maintaining extrusion processes to produce high- quality parts and components. This role involves interpreting technical drawings,… more
- Imperative Care (Campbell, CA)
- …designed, developed, and manufactured in compliance with customer needs, company quality systems, budget, schedule and regulatory requirements of the countries into ... device development in a start-up environment preferred. + Statistical analysis Software (Minitab or similar) and CAD (Solidworks, ProE, similar). + Demonstrated… more
- Abbott (Santa Clara, CA)
- …metal stents, guide wires, balloon dilatation catheters, imaging catheters and software , vessel closure devices and peripheral stents. This **Regulatory Affairs ... development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to achieve departmental and organizational… more
- Cordis (Irvine, CA)
- …under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation activities **Qualifications** + 7+ years as ... into system requirements, and lead continuous improvement initiatives that boost productivity, quality , and margins across the shop floor and the full product… more
- Terumo Neuro (Aliso Viejo, CA)
- …of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, ... launch, and post market phases. Work closely with R&D counterparts, Operations, Quality , and Regulatory in supporting the development of new products and… more
- Medtronic (Irvine, CA)
- …and prioritize tasks to meet project schedules + Interface with engineering, quality , clinical, marketing, and other functions as needed to fulfill responsibilities ... submissions and other worldwide submissions and clearances. + Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485,… more
- Fortive Corporation (Irvine, CA)
- …to enhance **manufacturing efficiency** . + Integrate **automation with production, quality control, and facility operations** . + Drive **process improvements and ... validation** for facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP, OSHA, and safety regulations** . + Support **regulatory audits… more
- Cognizant (San Francisco, CA)
- …of the client. + Grow our business across Life Sciences clients across Quality Engineering and assurance services + Meet client revenue targets, gross margins and ... account P&L). + Enable great customer experience and delivery quality . + Contribute to creation of content, write proposals,...facing role (client management, sales) at top consulting / software / IT Services / 3rd party analytics /… more