- Applied Materials (Santa Clara, CA)
- …semiconductor manufacturing equipment. . Familiarity with quality management systems (eg, ISO 9001) and their associated compliance requirements. **Project ... highly skilled and experienced PMO Professional to support our Product Regulatory Compliance program. This critical role ensures our products meet all applicable… more
- Applied Materials (Santa Clara, CA)
- …and the semiconductor industry. . Familiarity with quality management systems (eg, ISO 9001) and their associated compliance requirements. **Project Management** ... highly skilled and experienced Senior PMO to support our Product Regulatory Compliance program. This critical role ensures our products meet all applicable… more
- Medtronic (Northridge, CA)
- …position involves close collaboration with multidisciplinary and cross-functional teams to ensure compliance with ISO 10993 standards and global medical device ... biological assessments of material and device safety in accordance with ISO 10993-1 by conducting chemical characterization analysis impact assessments for changes… more
- Actalent (Irvine, CA)
- …process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971. + Develop and implement quality plans. ... and procedures related to medical device manufacturing + Working knowledge of EN ISO 13485, ISO 14971, IEC 62304 and FDA QSR for Medical Devices + Ability to… more
- TEKsystems (San Diego, CA)
- …regulated industries such as medical devices, aerospace, or automotive. + Experience with ISO , FDA, or other compliance frameworks. + Proven success leading ... lifecycle. This role is essential in ensuring the reliability and compliance of testing processes, driving continuous improvement, and collaborating with… more
- MKS Instruments Inc (Irvine, CA)
- …quality defects/concerns + Reviewing and updating QMS documentation and procedures in compliance with ISO 9001:2015 and customer-specific quality requirements + ... assemblies + Supporting customer audits, transfer validation, and regulatory compliance for semiconductor and aerospace customers + Support continuous improvement… more
- Medtronic (Santa Ana, CA)
- …shape memory alloys. Translate patient/physician needs into design input requirements in compliance with Design Controls Standards including ISO 5840. Leverage ... anatomy, and PDP; Designing implantable heart valves using SMA in compliance with ISO 5840; Mechanical Testing of heart valves, including tension, compression,… more
- Cognizant (Sacramento, CA)
- …business systems analyst with a deep understanding of business processes under GxP, ISO , and regulatory compliance Knowledge of Mfg. Process Controls and ... Reporting program Awareness of Electronic Lot History Records using Camstar Software for Medical Device/ Pharma industries Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry Experienced in… more
- Silvus Technologies (Los Angeles, CA)
- …with IT department + Collaborate with other process managers responsible for CMMC, ISO , and other compliance services + Compiling monthly summary of schedule, ... budget, and other relevant status for engineering and R&D departments + Overseeing the delivery of contractual requirements on funded engineering/R&D projects + Overseeing steps towards obtaining or maintaining various certifications with associated… more
- ThermoFisher Scientific (Fremont, CA)
- …groups as needed. + Implement and coordinate comprehensive quality assurance measures in compliance with ISO 13485 and FDA regulations. + Drive continuous ... Proven experience working in a cGMP laboratory setting. + In-depth knowledge of ISO 13485 and FDA manufacturing and quality assurance standards. + Strong background… more