- AbbVie (Waco, TX)
- …for reportability under 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance ... CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and other international complaint handling and vigilance regulations. + Experience… more
- Caris Life Sciences (Irving, TX)
- …SaMD products are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR, IVDR, SOX, SOC2, and IEC 62304 + Reviews and ... all requirements and documents. + Strong knowledge of SDLC process and the application of ISO 13485, FDA QSR, 21 CFR Part 11, IEC 62304, GAMP5, SOX, and SOC2… more
- TriMas Corporation (Longview, TX)
- …Quality Policy, including all items assigned to this position in accordance with ISO policies, procedures, and work instructions. Complies with the work rules and ... tasks in a reasonable time frame. . Adherence to the Quality Policy and ISO Procedural Requirements. . Maintain a clean work area and follow good housekeeping… more
- Rogers Corporation (Chandler, AZ)
- …alignment with enterprise goals and regulatory obligations (eg, SOX, NIST 800-NNN‑, ISO /IEC 27001, privacy laws). Primary alignment to NICE Systems Authorization and ... management, and third party risk. * Hands on with NIST control baselines, ISO /IEC 27001 controls, SOX ITGCs, and privacy obligations, * Experience with GRC… more
- IDEX (Brenham, TX)
- …and new product introductions. This role ensures compliance with ISO 9001 standards, leads continuous improvement initiatives, and collaborates cross-functionally ... excellence throughout the organization. **Key Responsibilities:** + Ensure adherence to ISO 9001 and internal quality management systems. + Develop and maintain… more
- Teledyne (Rancho Cordova, CA)
- …and qualification reports + Ensure compliance with industry standards (ASTM, ISO , ASME) and regulatory requirements + Collaborate with design, electrical, ... cause analysis and implement corrective actions (required) + Familiarity with ASTM, ISO , and ASME standards (required) + Master's degree in Materials Science,… more
- Jabil (Memphis, TN)
- …/ planning skills / interpersonal I communication skills. + Knowledgeable in AAMI/ ISO Radiation Sterilization Standards. + Familiar with ASTM Radiation and Dosimetry ... and experience in Good Manufacturing Practices, Good Documentation Practices and ISO standards. Education: + Bachelor of Science, from an accredited university… more
- Teledyne (Rancho Cordova, CA)
- …+ Conduct qualification tests (PQRs) and ensure compliance with AWS, ASME, and ISO standards + Perform metallurgical evaluations and NDT methods such as radiography, ... or related field with 5-7 years experience (required) + Familiarity with AWS, ASME, and ISO standards (required) + Must be a US citizen and able to obtain and… more
- Micron Technology, Inc. (Boise, ID)
- …Enforce company-wide QMS requirements and quality standards to ensure compliance with ISO /IATF standards. + Represent Boise Facilities in all internal and external ... and collaborator management skills. + Familiarity with QMS standards ( ISO /IATF) and audit processes. **Preferred Qualifications:** + Experience in semiconductor… more
- Datavant (Juneau, AK)
- …of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** . + Proven leadership in scaling ... or CRO quality teams. + Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. + Familiarity with supplier portals, quality… more
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