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Supports QMS activities related to Management Review, audits (internal and external), deviations, CAPA, NCR, supplier management, RGA, and etc. Develop, review, and approve inspection plans, DHR, and product drawings for new products.
$120,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Complete Nonconformance and/or CAPA related activities such as, regulatory reporting determination, risk assessment, investigation, root cause analysis, justifications as requested. Participate in the completion of Device History Records (DHR) or Donor Processing Records as applicable.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Perform prompt DHR review in compliance with FDA regulations and Good Documentation practices. Support CAPA process and follow-up to ensure CAPAs implemented are effective. The QA Manager will be responsible for monitoring and achieving department metrics and cycle times with adherence and compliance to cGMP/USP/ ISO and FDA guidance and requirements.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Assist in the development, improvement, and management of product assurance systems such as incoming quality inspection, in-process quality assurance, statistical process control, calibration / preventative maintenance, CAPA, nonconforming materials, product lot release testing, and finished goods control.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Lead nonconformance reports (NCR) and CAPA investigations. Lead the Device History Records (DHR) review and approval process. Lead nonconformance reports (NCR) and CAPA investigations.
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This position will assist with the development, implementation, and monitoring of the Quality Management System (QMS) to include the Corrective and Preventive Action (CAPA) System, Design Control, Change Control and Records Control, Document Control, Training Records, Device History Records (DHR) and various other elements within the quality systems as it relates to regulatory compliance and Erbe Quality Systems.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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This role will also be responsible to ensure that sophisticated device history records DHR are maintained in an organized manner and able to be assembled quickly for audit purposes. Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Support review and maintenance of manufacturing Device History Record DHR. Perform instrument release activities. The Quality Ops Analyst recommends CAPAs and SCARs based on top issues seen from NC activities and supports the compilation of device master records device history records training records CAPA records and other Quality System records.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Support review and maintenance of manufacturing Device History Record (DHR). Support review and maintenance of manufacturing Device History Record (DHR). The Quality Ops Analyst works with relevant departments to ensure successful implementation of quality systems and communicates the impact of changes to areas affected to ensure that the changes are integrated into day to day operations.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Provide oversight as needed for DHR/Batch Record Review. Additionally, the Quality Operations Manager participates in and ensures the QA Technicians participate in Non-Conformance investigations, ensuring thorough investigations, accurate Root Cause Analyses and appropriate CAPA and effectiveness checks.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Support the DHR process by collecting, auditing, and filing documentation. Extensive quality review experience to include: DHR review, product quality review, process deviation review, engineering change reviews for quality, nonconforming materials reviews for quality.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Quality Assurance Lead for Contact Lens manufacturing platform in the Rochester facility is responsible for supporting the quality system structure (DHR, process control plan, PFMEA, participate in design control activities, etc.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Quality Ops Analyst I coordinates and participates in internal audit activities and key quality initiatives as appropriate. Quality or Compliance related experience in IVD, Medical Device, or Biotechnology organization.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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This will include DHR review, NCR and CAPA generation, processing, creation of quality records, risk assessment, ownership of all document control workflows, and support Management Review.
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This role is responsible for the hold and release of raw materials and finished goods, through the QA Techs, to meet regulatory and performance specifications. Provide ongoing education and training as needed for production associates relative to cGMP, Deviations, NCMs, and other components of the Quality System.
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