- WATTS (Menomonee Falls, WI)
- …product lines, material inspection, testing, and evaluation in accordance with ISO standards. + Facilitate effective product/process corrective actions (CAR) using ... audits (LPA) and Finished Good audits, to improve compliance with ISO procedures, specifications, and performance requirements. + Manage and implement effective… more
- Access Dubuque (Dubuque, IA)
- …find a **Quality System Manager** to lead and maintain the company's ISO 9001:2015 Quality Management System. **Key Responsibilities:** + Coordinate and maintain the ... company's ISO 9001:2015 Quality Management System + Ensure ISO documentation, procedures, and forms are up to date and accessible + Organize and lead internal… more
- Clarios (Plymouth, MI)
- …product engineering lifecycle, ensuring alignment with ASPICE process models and ISO 26262 Functional Safety activities. You will work cross-functionally with system ... standards. + Define and maintain cybersecurity engineering processes aligned with ISO /SAE 21434 across the V-model lifecycle. + Integrate cybersecurity activities… more
- Oracle (Helena, MT)
- …is responsible for Interpreting and translating healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) ... to + Interpret and translate healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) into concrete SDLC… more
- NRG Energy, Inc. (Houston, TX)
- …in a timely and accurate manner in accordance with management and ISO requirements + Create and submit Current Operating Plans (COP) accurately communicating ... transactions in a timely and accurate manner in accordance with management and ISO requirements + Understand the basics of load resources and schedule them… more
- Cummins Inc. (Columbus, IN)
- …on Standards** : Maintain up-to-date knowledge of internal changes and external standards ( ISO 9001, IATF 16949, AIAG core tools, CSR) to ensure compliance and ... : Own and maintain the audit plan/schedule and records for ISO /IATF internal audits and manufacturing process audits, ensuring thorough documentation and… more
- Merck (Rahway, NJ)
- …ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971). This position will interact with cross-functional ... device and drug combination products (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971) + Collaborate with cross-function teams to improve processes related to… more
- PCI Pharma Services (Madison, WI)
- …GMP and safety controls + Guide and train employees to ensure QSR and ISO requirements have been properly implemented and are continually met. Partner with Quality ... set and production records reflect practice, are aligned to cGMPs/ ISO and corporate standards + Provide support of batch...+ Ability to gown and maintain entry into the ISO -05 Cleanroom area + Ability to wear personal protective… more
- Caris Life Sciences (Phoenix, AZ)
- …laboratory, operational, and customer-facing functions to maintain compliance with FDA, ISO 13485, CAP, and CLIA requirements while driving data-informed continuous ... global Quality System and Regulatory framework, maintaining compliance with applicable FDA, ISO 13485, CAP, and CLIA standards. The analyst contributes to continuous… more
- J&J Family of Companies (Santa Clara, CA)
- …post-market surveillance is required. + Successful history leading FDA inspections, ISO certification audits, and MDSAP assessments, with a strong understanding of ... global regulatory requirements. + Proficiency in 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, ISO 27001, and EU MDR compliance… more