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Submitting and maintaining test result documents Working directly with manufacturing and engineering personnel to test and inspect components and materials Promoting the smooth flow of products through quality control to disposition Providing test and inspection support to all new process developments Reviewing Device History Records (DHR) Reviewing all lab results and approve product release.
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Generates required documentation to complete the Device History Record (DHR) Conducts production testing of assembled flow cytometers and related medical device products. Experience working in a medical device manufacturing organization.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Knowledge of LEAN Manufacturing, Six Sigma tools and concepts, Demand Flow Technology (DFT) Experience testing and troubleshooting: laser based optical systems, fluidic systems, digital and analog circuitry.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Review all Device History Records (DHR) and approve prior to product release. This position will be responsible to maintain the QMS, facilitate external and internal audits, ensure completion of nonconformances, CAPA’s, complaints, document control and change controls.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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We are a medical device startup company at the transition from R&D and is working on a family of therapeutic medical devices that will save people's lives. 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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Performs instrument optimization functions after final assembly: laser alignment, pressure adjustments, electrical adjustments, etc. Experienced in the use of: DVM's, Oscilloscope and general aaaaa equipment.
ExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Experience in Device Quality System, Design, Manufacturing and Testing, 21 CFR Part 820, DHF, DHR, DMR, and overall Device Regulations, CDRH and 510 k or PMA approvals are a plus.
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Ensures the DHR (Device History Record) is complete and accurate, including all approvals, prior to forwarding the Work Order kit for further processing. Previous experience or exposure to medical device manufacturing processes is desired.
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Prepares and assembles Device History Record(DHR) paperwork for use in the production of Finished. Insures proper handling of hard copy file device BRM and associated changes related to CPS.
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Participate in the completion of Device History Records (DHR) or Donor Processing Records as applicable. Three (3) - five (5) years' experience in Quality Assurance and/or Regulatory Affairs for medical device or related industry.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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0-2 years’ experience with electronic assembly and test, preferably in medical device industry. Maintain accurate records to ensure DHR and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Understanding of documentaion procedures, device batch records (DHR) Data History Records and able to populate data with no error. 2-5 years in an ISO environment (FDA regulated Medical Device industry is a plus.
$19 - $21 an hourExpandUpdated 2 days ago - UpvoteDownvoteShare Job
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Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations. Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations.
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Monitor, track, and trend stability data and GMP quality systems and establish metrics. We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute treatment of migraine, with or without aura, in adults.
$160,000 - $225,000 a yearFull-timeExpandUpdated 6 days ago - UpvoteDownvoteShare Job
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Medical device, regulatory environment or pharmaceutical manufacturing is a plus. This person will collaborate with manufacturing sites and TPMs to access DHR records to perform DHR review.
Full-timeExpandApply NowActive JobUpdated 5 days ago
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