- embecta (Parsippany, NJ)
- …of design control processes in compliance with quality standards such as 21 CFR 820.30, ISO 13485, and ISO 14971. + Champion the development and maintenance of ... risk management files per ISO 14971, ensuring complete traceability from hazard identification to...knowledge of FDA and international regulations. + Expertise in ISO 13485, and ISO 14971, including other… more
- Anoplate Corporation (Syracuse, NY)
- …industry specifications, on-time delivery, and cost targets while maintaining compliance with Nadcap, ISO 9001, and ISO 14001 standards. This leader fosters a ... Uphold industry-leading safety, environmental, and quality standards. Maintain compliance with ISO 9001 and ISO 14001 while reducing rework, improving… more
- BigBear.ai (Columbia, MD)
- …preparation of a work product in Technical Process Areas associated with the ISO /IEC 15288 Perform systems engineering activities and assist in the preparation of ... products in Project and/or Technical Process Areas associated with any of the ISO /IEC 15288 processes. Assist in performing systems engineering activities in the … more
- ERCOT (Taylor, TX)
- …Works closely with ERCOT Subject Matter Experts (SMEs) to ensure that ERCOT ISO meets or exceeds the reliability performance requirements in accordance with ERCOT ... the all ERCOT regulatory standards requirements + Monitors and reports ERCOT ISO and Market Participant Reliability performance in accordance with ERCOT Protocols… more
- Medtronic (Irvine, CA)
- …complexity of government and medical device industry regulations including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and ISO 9001 standards to ensure ... years of experience with each of the following: FDA 21 CFR Part 820, ISO 13485, ISO 14971 & ISO 9001; Good Manufacturing Practices (GMP); Risk activities… more
- Kratos Defense & Security Solutions, Inc. (Orlando, FL)
- …systems and their integration within the overall project, ensuring compatibility with BIM standards ( ISO 19650, ISO16739-1, ISO 12006-2, ISO 23386, ISO ... of processes, procedures, and designs adhering to relevant industry standards (eg, ISO 19650, relevant national BIM standards, ASME codes) and best practices within… more
- Invenergy (Chicago, IL)
- …Overview The Sr. Manager will provide operational oversight for Invenergy's RTO/ ISO Market Registrations and Operational Compliance programs. In this role, the ... existing programs responsible for regional and independent transmission organizations ("RTO/ ISO ") market registrations, training, and compliance demonstration with Market… more
- System One (Malvern, PA)
- …as needed or required. Knowledge, Skill, and Abilities: + Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, MDSAP and US/global UDI ... for class II medical devices including but not limited to 21 CFR 820, ISO 13485, ISO 14971, ISO 10991, EU MDR, and MDSAP. + Direct experience with… more
- ManpowerGroup (Tigard, OR)
- …inspections, precise measurements, and adherence to Good Manufacturing Practices (GMP) and ISO guidelines. Your work is critical to maintaining our reputation for ... improvement of quality systems + Ensure compliance with GMP, ISO 9000, and ISO 13485 standards **Minimum Qualifications:** + Associate's Degree in Biology,… more
- Actalent (Fort Worth, TX)
- …affairs + Process and equipment validation + Documentation control + Quality Control + ISO 9001 / ISO 13485 + Solid understanding of scientific and engineering ... Health Canada regulations, and IMDRF frameworks + Understanding of ISO 14971 (Risk Management) and ISO 10993...Understanding of ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility) + Experience with Design Control and… more