• Cytiva (Miami, FL)
    …and PLM systems. Performs evaluation of internal controls, and maintenance of documentation as related to compliance with internal and external quality and ... controls that align with applicable regulatory requirements. Ensure compliance with documentation requirements defined in ISO 9001, ISO 14000and OSHA PSM and… more
    JobGet (05/07/25)
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  • Beckman Coulter Life Sciences (Miami, FL)
    …ISO 14971), Production, Service Controls. Assuring compliant process and product documentation , inclusive of Design History, Product, Process and Service ... documentation in support of product realization and commercialization within the Beckman Coulter quality system.Awareness of current industry standards and… more
    JobGet (05/06/25)
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  • Beckman Coulter Diagnostics (Miami, FL)
    …equipment standards and regulations.Administer and maintaining product compliance documentation (Tech files/NRTL/IEC test reports).Track, interpret, assess and ... thinking skills to lead the work related to generating safety documentation and making design recommendations on compliance related findings.Experience with product… more
    JobGet (05/01/25)
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  • Cytiva (Miami, FL)
    …project outcomes.. Authoring and overseeing the detailing of documentation , including engineering drawings, tolerances, technical specifications, verification plans ... and reports.. Leveraging Cytiva's robust QMS systems and tools to facilitate and manage design transfer from R&D to Cytiva's manufacturing and supply chain teams, and with relevant Contract Manufacturing Organisations. Contributing towards the short, medium… more
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  • Aldevron (Miami, FL)
    …data to be included in technical reports following all appropriate good documentation practices.Develop solutions for simple and complex problems requiring a high ... degree of ingenuity, creativity, and innovation. Broaden existing expanded knowledge in own field, to other areas relevant to team operations.Be an individual contributor with minimal supervision. Perform experiments, analyze data, and plan next steps with… more
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  • Beckman Coulter Diagnostics (Miami, FL)
    …or other regulated industry (particularly supporting testers & documentation requirements within the manufacturing operations space)Other engineering discipline ... exposure / background (software: C#, VB, C++, Python, Powershell, LabView, etc., mechanical: 3D modeling or printing with any CAD package such as SolidWorks, Fusion, etc., IT: virtual machines, legacy operating systems, networking, etc.)The salary range for… more
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  • Pall (Miami, FL)
    …questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for ... and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on… more
    JobGet (05/01/25)
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  • Pall (Miami, FL)
    …up and qualification of manufacturing equipmentGenerate essential drawings and documentation for fabrication and installation of manufacturing equipmentWho you ... are:Knowledge of engineering fundamentals as typically acquired by completion of a Bachelor of Science in mechanical engineering or chemical engineering.Experience in AutoCAD, any version (required)Knowledge of manufacturing processes and their direct impact… more
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  • Cytiva (Miami, FL)
    …other departments to ensure smooth operations.Develop and maintain process documentation , including standard operating procedures (SOPs), process flows, and ... validation reports.Design, test, and implement new manufacturing processes, equipment, or systems to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA, ISO, PSM) and contribute to audits and… more
    JobGet (05/01/25)
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  • Aldevron (Miami, FL)
    …the application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and EU regulations ... specific to labels and labeling such as 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and international guidelines#LI-GC1#LI-OnsiteJoin our winning team today. Together, we'll accelerate the real-life impact of tomorrow's… more
    JobGet (05/01/25)
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