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Generates required documentation to complete the Device History Record (DHR) Analyzes test results on defective units to determine root cause of failure. Requirements: Requires an Associate's degree (A.S.) or equivalent from two-year college or technical school 3+ years related experience in a high tech, manufacturing environment Ability to effectively communicate information and respond to questions both verbally and in writing.
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Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations. Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR.
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DHR review - review batch records for med device. This person will ensure the quality of manufactured products and processes per standard operating processes (SOP) and GMP (Good Manufacturing Practices.
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Support production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
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Position Description:The Quality Control Inspector will review device history records & document their work on the DHR. Inspect components utilizing inspection equipment. Perform quarantine and receiving inspection of incoming raw materials, controlled manufacturing materials, machined components, labeling instrumentation, and packaging materials.
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The Senior Quality Inspector supports manufacturing and servicing operations by performing incoming component and in-process product inspections which are more complex requiring the use of sophisticated measurement systems and instrumentation.
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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. · Requires solid computer knowledge (Windows/ERP/Manufacturing systems applications) for material issuance, inventory tracking and control, and completing MES transactions.
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Familiarity with FDA regulations related to medical devices including DHR, GDP, GMP, Complaint Handling, etc. Perform Product Record Review (paper record review) of non-return complaints (DHR, Risk, Labeling, and other records.
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Lead the Device History Records (DHR) review and approval process. 5+ years of experience related to the manufacturing of medical devices in a QMS environment while being in a Quality Control or Engineering role.
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Coordination with Manufacturing associates for completion/correction of DHR errors. Completes batch record review at final stage of the manufacturing process with minimal assistance and approves their final release once it has been determined that all compliance and procedural requirements have been met.
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Utilize basic measurement tools to inspect parts (Micrometers, calipers, height gage, thread gage, scales, pin gages, etc.) Process service records for Client Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness, and correctness.
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This position is responsible for conducting routine inspection and analysis of incoming service material and quality reviews of domestic and international service records by identifying conflicts, dependencies, and risk of release to ensure Quality Assurance Standards and procedures are met.
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Assembles product packages per DHR, special instructions, and video imaging. Manufacturing is responsible for cost of production and maintenance activities including process improvement, supply chain management, quality assurance, employee safety and engagement, and environmental commitment.
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Clearly document testing results that are required for IABP DHR. •Perform the final manufacturing process of the semi-finished IABP. Adecco Staffing is assisting a well-known Medical Device Manufacturing facility in Chelmsford MA with their need for a Test Technician on 1st Shift.
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Supervises personnel responsible for incoming and final inspection as well as batch records (DHR) review. May serve as backup reviewer for DHR reviews. With an expertise in contract manufacturing, our in-house product design and mold making, accelerated tooling, and strong up-front engineering allows us to control and support programs at all levels.
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