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Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Candidate must be industrious, agile, ability wok in different time zones and able to travel across the globe (NA/Asia/EU/KSA) to collaborate with internal and external stakeholders for QMS development.
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Be visible and voice of SIE QMS team by generating regular reports for senior management, highlighting TPM/SIE/Supplier performance, OKRs-Goals-KPIs, risks, and strategies for QMS improvement.
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Quality Systems Engineer - Manufacturing QMS. QMS Implementation: Implement and improve Quality systems and processes that are not compliant with Oatey standards. Prior experience as a QMS Auditor in a manufacturing environment, 3-5 years of related experience is required.
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Familiarity with relevant technologies, databases, and PLC programming languages used in manufacturing ERP and MES-QMS systems. Oversee and participate in technical data migration activities for the manufacturing ERP, MES, and QMS systems.
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They shall be familiar with the quality management system (QMS) and will perform audits of the same. Perform internal QMS and Process audits. Familiar with NDT Inspections (MT (magnetic particle testing), UT (ultrasonic testing), PT (liquid penetrant testing), MFL (magnetic flux leakage), VT (visual testing), Phased Array, etc.
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Collaborating with cross-functional groups including Manufacturing, Quality Control, IT, Engineering, and Validation to identify risks, develop mitigation strategies, and resolve issues, ensuring the smooth functioning of Quality systems including TrackWise QMS, Veeva and Labware.
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The company is widely regarded as a leader in providing business consulting, systems integration and ongoing support services focused on Content Services and its applicability to business-critical solutions including RIM, Regulatory, Clinical and QMS. fme is partnered with the leading Business Solutions and ECM vendors supporting the Life sciences industry, including Veeva, OpenText/Documentum, Generis (Cara), Sparta and Alfresco.
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How You’ll Make An Impact: Collaborate with Quality Systems Manager and Global Design Quality Assurance organization to support initiatives in risk management, QMS harmonization, training, QMS performance monitoring and internal and external audits.
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Proficiency in MS Office suite, statistical tools (Minitab/JMP), QMS and CAD/PLM systems. High proficiency in creating/improving Quality Management Systems (QMS) or Supplier Management Strategies.
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Position SummaryThe Supervisor, Sterile Processing will provide onsite support, training, Customer Service, and communication regarding the processing of surgical instruments and staff management to contracted facilities in compliance with STERIS Standard Work or QMS, the Department of Health, TJC, DNV, OSHA, CDC, AAMI and AORN standards, and facility goals and policies.
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Collaborate with Quality Systems Manager and Global Design Quality Assurance organization to support initiatives in risk management, QMS harmonization, training, QMS performance monitoring and internal and external audits.
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The Supervisor, Sterile Processing will provide onsite support, training, Customer Service, and communication regarding the processing of surgical instruments and staff management to contracted facilities in compliance with STERIS Standard Work or QMS, the Department of Health, TJC, DNV, OSHA, CDC, AAMI and AORN standards, and facility goals and policies.
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And management of an electronic document management system (EDMS/LMS/QMS), periodic review of SOPs and archival of quality records, and maintaining the GxP training program, including new hire onboarding.
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Assures completion of QMS laboratory reports for each laboratory within Bassett Healthcare Network. The QMS Technical Specialist is responsible for meeting laboratory regulations (NYSDOH, The Joint Commission, and American Association of Blood Banks) as they relate to quality as well as organizational performance improvement and service excellence.
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