- Neotech (Chatsworth, CA)
- …to ensure compliance with customer requirements, FDA regulations & ISO specifications. + Support Corrective Action/Preventative Action initiatives relating to ... + Manage & support required technical and procedural training for IPC and ISO . + Assist in maintaining & reviewing necessary training requirements as related to… more
- AECOM (Sacramento, CA)
- …and external quality audits following client procedures and best practices from ISO 19011 guidelines + Monitor and support the issuance, resolution, and closure ... working on megaprojects + Experience working in organizations certified to ISO 9001 and ISO 45001 + Experience supervising and managing small work teams,… more
- J&J Family of Companies (Santa Clara, CA)
- …/ program teams to ensure software deliverable comply with RADS procedures, global ISO standards ( ISO 13485, ISO14971, IEC62304), regulations (eg 21 CFR Part ... + Working knowledge of IEC 62304, FDA's General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR part 820, IEC 60601-1 and MDR. + Ability to… more
- Danaher Corporation (Sunnyvale, CA)
- …corrective action . + Participate in external audit management ( eg FDA, ISO , Danaher Corporate, foreign governments), in either a supporting or lead role, related ... standards including compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR)...including, but not limited to, 21 CFR Part 820, ISO 13485, MDSAP country related requirements TGA, ANVISA RDC… more
- Medtronic (Northridge, CA)
- …biological evaluations within a risk management framework, ensuring compliance with ISO 10993 standards and global medical device regulations. This role involves ... and other duties may be assigned. + Acquire working knowledge of ISO 10993 standards for biocompatibility. Maintains knowledge of the latest standards, regulations,… more
- NVIDIA (Santa Clara, CA)
- …What you will be doing: + Leading execution of safety engineering processes to meet ISO 26262 and ISO 21448 standards, with on-time safety case completion + ... functional safety and development processes needed to follow the ISO 26262 functional safety standard + A working knowledge...autonomous vehicle systems + Experience in the application of ISO 21488 (SOTIF) in combination with functional safety +… more
- Crane Aerospace & Electronics (Los Angeles, CA)
- …local environmental and safety regulations and third-party certifications such as ISO . The role involves hands-on participation, evaluating and clarifying EHS ... Audit:** + Develop and implement an effective EHS management system aligned with ISO :14001:2015. + Drive a culture of EHS compliance and results to prevent… more
- Crane Aerospace & Electronics (Los Angeles, CA)
- …and enforce Quality Management System (QMS) in accordance to all internal, external ( ISO 9001, IATF 16949, ISO /IEC 80079-34, and ATEX Directive), and customer ... and/or facilitate 1st, 2nd, and 3rd party audits in the ISO 9001, IATF16949, ISO /IEC 80079-34, VDA, CQI, and ATEX Directive environments. + Participate in… more
- CTG (Woodland, CA)
- …in-house and external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures. **Requirements** * Ensure compliance with new ... resource for customer regulatory and technical inquiries * Maintain ISO 13485-based quality system * Implement and manage CAPA...in support of internal requirements, 21 CFR 820, and ISO 13485 compliance * Represent the organization in customer… more
- pony.ai (Fremont, CA)
- …functionally to develop engineering solutions based on existing automotive industry standards (Ie. ISO 26262, ISO 21448, UL 4600, IEEE 2846, etc.) that help ... background + Working knowledge of relevant standards and methods such as ISO 26262 and ISO 21448 + Experience performing System Safety Engineering tasks for ADAS… more