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We are seeking a highly skilled Quality Assurance/Quality Control Analyst who has experience in testing large scale software solutions to support the transition of the PDR from John Hopkins to DHR/ISD and to work on projects of moderate to high complexity for the transferred PDR system.
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The Quality Control Inspector will review device history records & document their work on the DHR. Inspect components utilizing inspection equipment. Utilize electronic systems to maintain training records.
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Reviews Device History Records (DHR) and Incoming Inspection documents for accuracy, completeness and compliance with specifications as per applicable departmental procedure(s) for review of quality records.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Ensures that any non-conformances or deviations are properly approved and documented in the DHR. Works collaboratively with internal customers to resolve DHR issues in a timely manner. Reviews and approves records from sterilization sub-contractors to assure sterility of single use products.
$57,100 - $90,900 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Supports activities ensuring all records and DHR documentation adhere to cGMP/GDP expectations and product release occurs in timely manner. Reporting directly to the Director of Quality Operations, the Quality Engineering Manager, USA Manufacturing provides oversight of a variety of analytical functions that occur in the QE department supporting validation, testing, process control, failure investigation, and disposition.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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As a member of the Review/Release Quality Control Group in Waltham, you will be responsible for performing the review of Device History Records (DHR), the inspection of labels/final products, the performance of line clearances, and possibly the processing of Non-Conforming Materials in support of Manufacturing's schedule.
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Perform review of device history records (DHR) for compliance to manufacturing and inspection procedures, equipment settings, calibration requirements, material usage, inspection results, and good documentation practices.
$73,000 a yearFull-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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Responsibilities: Perform thorough examinations of all materials and finished products DHR Reviews, sterile goods focus Receives, inspects, tests, and properly documents incoming components, assemblies, and finished good.
$20 - $26ExpandApply NowActive JobUpdated Today - 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. Assemble device history records.
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Insures proper handling of hard copy file Device History Records (DHR) and associated changes related to CPS manufacturing. Works with Assembly Supervisor to develop daily work schedule for CPS production requirements.
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Document Handling: Review, organize, and file completed Device History Records (DHR) as per SOPs. Document Handling: Review, organize, and file completed Device History Records (DHR) as per SOPs.
$32 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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What Your Day-To-Day Will Involve: Represent Quality in Capital Equipment Production and Service Operations Assist in and/or perform final review of manufacturing DHR (Device History Records) Perform labelling and packaging inspection for CE, Warehouse, and Service Production Compile and archive completed and approved DHR Compile and archive completed and approved incoming inspections records as required.
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Documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR) Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches.
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Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve questions, inconsistencies, or missing data issues. The Quality Records Coordinator oversees the archives of DHRs, Device Master Records (DMRs) and other quality records, and is responsible for maintaining accuracy, legibility, traceability, and retrieval of such records.
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Understanding of documentation procedures, device batch records (DHR) Data History Records and able to populate data with no error. Other duties assigned by manufacturing supervisor and or line leader.
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