- Oberg Industries (Freeport, PA)
- …of manufacturing space, 6 manufacturing facilities with rapid access to capital and we are ISO 9001:2015, ISO 13485:2016, and AS 9100 Rev. D certified, ITAR and ... FDA registered. Come be part of the next chapter in our Oberg Story! OBERG BENEFITS: At Oberg Industries, LLC employees enjoy a comprehensive benefits package including: + Competitive Pay + Medical, Dental and Vision Insurance (no premiums paid) + Medical… more
- Ford Motor Company (Dearborn, MI)
- …compliance with all relevant regulatory and internal requirements, including NIST 800-53, ISO 27001, SOC 2, GDPR, and CCPA, across both cloud infrastructure and ... and documenting controls based on various security frameworks, including NIST 800-53, ISO 27001, SOC 2, GDPR, and CCPA. * Exceptional leadership, communication, and… more
- Mentor Technical Group (Caguas, PR)
- …- assist in process validation protocol. * Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends. * Perform quality ... system audits to determine compliance to FDA, ISO , and internal quality systems regulations and perform quality system surveys to evaluate the overall quality… more
- Hologic (Marlborough, MA)
- …FDA Quality System Regulations, particularly Design Control requirements. + In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk ... Management). + Familiarity with test method validation, root cause failure analysis, and statistical methods. + Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components. + Awareness of… more
- Celestica (Boise, ID)
- …execution by Celestica product design partners. + Understanding ISO 13485 requirements for medical device engineering changes. **Knowledge/Skills/Competencies** ... Understanding of IEC 60601-1 Electrical Medical Device Safety Standard. + Understanding of ISO 13485 as it relates to Design Control for medical devices. +… more
- Legrand NA (Kenosha, WI)
- …or exceed established standards. Ensure all production is compliant with established ISO standards and all personnel assigned are properly trained to sustain ... blueprints + Demonstrated experience with a QMS, Lean, Six Sigma, and ISO + Experience establishing and managing preventative and predictive maintenance systems +… more
- J&J Family of Companies (Santa Clara, CA)
- …relevant experience + Related Quality System Certification is a plus + Experience with FDA/ ISO Audits, NCR, and CAPA experience is a plus + Proficiency in data ... written and verbal communication skills + Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems + The ability to understand and follow QMS… more
- Praxis Technology (Queensbury, NY)
- …. Lean and/or Six Sigma certification preferred but not required . Working knowledge of ISO 9001, ISO 13485 and AS9100 preferred but not required . Working ... knowledge of MasterControl or an electronic QMS preferred but not required Praxis is an equal opportunity employer Department Engineering Employment Type Full-Time Minimum Experience Experienced Compensation DOE more
- Tenet Healthcare (Detroit, MI)
- …standards. Serves as the Site Environmental Management Representative for the ISO 14001 program. Provides technical support to Directors/Managers of site departments ... regulating agencies. Safety Management, Fire Safety, Hazardous Material Management, ISO 14001, and local and regional Emergency Preparedness. 3. Qualification… more
- ALBEMARLE (Charlotte, NC)
- …CAPABILITIES** + Deep expertise in procurement and third-party risk management frameworks ( ISO 31000, COSO, etc.) + Familiarity with risk intelligence platforms (eg, ... preferred). + Experience implementing or operating within procurement risk frameworks ( ISO 31000, COSO). + Familiarity with risk intelligence tools (Resilinc,… more