- Danaher Corporation (Sunnyvale, CA)
- …and fabrication + Familiarity with DOE (Design of Experiments), validation protocols including IQ , OQ, and PQ + Proficiency with Auto CAD and or Solid Works ... + Proficient in data analysis using Minitab or similar statistical tools. It would be a plus if you also possess previous experience in: + Experience working with a variety of sensor technologies. + Hands-on machining experience Cepheid, a Danaher operating… more
- ZOLL Medical Corporation (San Jose, CA)
- …all necessary reference documentation exists and is audit ready. + Support IQ 's, OQ's and PQ's when introducing new or changing existing manufacturing equipmen ... + Works with vendors to address issues and to identify opportunities to reduce cost. Coordinates efforts with Supplier Quality Engineer. + Comply with all policies and standards. + Provides leadership, direction, and ownership in areas of manufacturing… more
- Fortive Corporation (Irvine, CA)
- …equipment. Hands-on experience with equipment installation, troubleshooting, and validation ( IQ /OQ/PQ). Familiarity with industry codes and standards (ASME, ASTM, ... ISO, FDA). Excellent analytical, problem-solving, and project management skills. Strong communication and interpersonal abilities. **Preferred Qualifications:** Experience with autoclaves and assembly manufacturing equipment. Working knowledge of PLCs,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …5 days a week. **Specific Job Responsibilities** + Using both EQ and IQ to effectively communicate ideas and influence decisions with associates across the Devices, ... Packaging, & Process (DPP) organization, Commercial, Marketing, Program Strategy Teams, and other Pharmaceutical Manufacturing & Development (PDM) functions, help develop both the vision and an actionable plan for a comprehensive long-term innovation pipeline… more
- J&J Family of Companies (Santa Clara, CA)
- …MDD and other applicable regulations. + Experience and understanding Process Validations ( IQ , OQ, PQ), 6S, Lean Manufacturing + Experience applying statistics and ... using statistical software, running Capability Studies (Cpk's), and planning and analyzing DOE's. + Demonstrated proficiency in written and verbal communication, including creating and delivering presentations. + Ability to use special software such as:… more
- J&J Family of Companies (Santa Clara, CA)
- …and Six Sigma concepts. + Experience with Validation of Medical Devices ( IQ -OQ-PQ). + Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE's, Gage R&R) ... a plus. + Able to create and maintain Drawings in SolidWorks. + Ability to work in a fast-paced environment while managing multiple priorities. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + Experience with… more
- Fortive Corporation (Irvine, CA)
- …(BMS) and Environmental Monitoring Systems (EMS)** maintain GMP compliance. + Lead ** IQ , OQ, PQ validation** for facility, automation, and process systems. + Ensure ... compliance with **FDA, EMA, GMP, OSHA, and safety regulations** . + Support **regulatory audits and inspections** , maintaining required documentation and training programs. **Team Leadership & Project Management** + Builds a cohesive that drives the goals of… more
- HP Inc. (Palo Alto, CA)
- **Who We Are** HP IQ is HP's new AI innovation lab. Combining startup agility with HP's global scale, we're building intelligent technologies that redefine how the ... world works, creates, and collaborates. We're assembling a diverse, world-class team-engineers, designers, researchers, and product minds-focused on creating an intelligent ecosystem across HP's portfolio. Together, we're developing intuitive, adaptive… more
- Interstate Blood Bank (Vista, CA)
- …+ Schedule and perform validation studies to meet production and requalification, IQ , OQ, PQ, CV, and PV requirements. This position requires giving instruction ... to personnel in other departments over which he/she has no direct authority. + Advise production managers and supervisors in the performance of validation activities and adapt the validation schedule to production requirements + Coordinate validation… more
- Stryker (Fremont, CA)
- …including design of experiments, equipment specifications, fixture designs, and IQ /OQ/PQs. + Demonstrated experience developing sterile packaging design and ... processes for syringes or injectors for liquids/formulations. + Knowledge in labeling systems and IFU development. + Experience with statistical analysis tools such as Minitab. **$130,700 - $215,300** salary plus bonus eligible + benefits. Individual pay is… more