- Teleflex (Pleasanton, CA)
- …* Expertise in SolidWorks. * Exceptional verbal and written communication skills. * Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and ... FDA QSR. * Experience developing mechatronic products with IEC 60601 is a plus. * Medical device experience is required. * Experience in robotics, motor control systems, embedded systems, or hardware/software integration is a plus. **Specialized Skills / Other… more
- Stryker (Memphis, TN)
- …active, industry-recognized cybersecurity certifications. + Understanding of NIST, ISO , and related security frameworks, particularly in vulnerability management. ... of medical device regulations (eg, US FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA cybersecurity guidance). 115,600.00 to 245,800.00… more
- Tecomet (Claypool, IN)
- …demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations. + Good Manufacturing Practices (GMP) and Good Documentation Practices ... in quality within medical device manufacturing industry preferred + ISO 13485, FDA 820 and customer interaction experience preferred...+ Quality Systems. + Regulations - FDA, GMP and ISO . + Blueprint reading. + GD&T. + Metrology. +… more
- Alkegen (Council Grove, KS)
- …+ Manage the quality systems for the facility and assure compliance to ISO 9001 requirements + Provide product specific expertise to support the Sales, Marketing ... Experience: + 5+ years of Quality leadership in an ISO 9001 system Skills and Abilities: + Proven leadership...skills required (Excel, Access, etc.) + Experience in implementing ISO 9001 preferred + Must be able to function… more
- Nomad Global Communication Solutions (Columbia Falls, MT)
- …+ Plan and execute internal, supplier, and compliance audits in accordance with ISO 9000, and other applicable standards. + Prepare detailed audit reports with ... leading Lean Six Sigma projects with measurable results. + Strong knowledge of ISO , or other relevant regulatory standards. + Experience with ERP, QMS, or data… more
- ZF (Vernon Hills, IL)
- …goods and all core, inbound part/unit, and non-compliant shipments according to established ISO procedures. + Bill credits for returned goods that meet ISO ... + Intermediate PC skills required. + Exposure to TQM's and knowledge of QS/ ISO 9000. Forklift experience with Reach trucks, Manup and Sitdown required. Proper use… more
- Tecomet (Lansing, MI)
- …demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations. + Good Manufacturing Practices (GMP) and Good Documentation Practices ... in quality within medical device manufacturing industry preferred + ISO 13485, FDA 820 and customer interaction experience preferred...+ Quality Systems. + Regulations - FDA, GMP and ISO . + Blueprint reading. + GD&T. + Metrology. +… more
- Ralliant (Atlanta, GA)
- …Technical Oversight * Support and perform hands-on calibrations in accordance with ISO /IEC 17025 and other relevant standards (ISO9001, AS9100, ANZ540.1). * Review ... escalate issues as needed. * Support audit preparation and actively participate in ISO , ANZ, and AS audits. * Participate in and support process improvements,… more
- Link Solutions Inc (Mclean, VA)
- …future of the technology landscape, look no further than Link Solutions. We are ISO 9001:2015, ISO 20000-1:2018, ISO 27001:2022 certified and appraised for ... CMMI ML3 for Services and Development. Link Solutions Inc. is seeking a dedicated Corporate Finance and Contract Senior Manager to join our team in McLean, VA. + US Citizen + Bachelor's degree + Experience working in government contracting, focusing on… more
- BorgWarner Inc. (Wilsonville, OR)
- …HIL/vehicle testing, data acquisition, and acceptance criteria; understand implications of ISO 26262 interface and OEM standards when required. 3) Issue Triage, ... gate‑driver design constraints, and power stage limitations. + Working knowledge of ISO 26262 safety interfaces and ISO 21434 cybersecurity at system/application… more
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