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Provide technical review of supplier batch records for development/tech transfer and related GMP documentation (e.g., raw material and product specifications, equipment specifications, validation protocols/reports.
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As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.
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Hands-on expert with High-Speed PCB Design and productizing: schematics capture, placement, layout (supervision); PCB/PCBA, BOM, Components; DFT/DFM; PCB Bring-up, Debugging, validation firmware integration; troubleshooting, customer support Failure Analysis (FA/RMA), sustainability; FCC regulatory, EMI complianceExcellent knowledge and hands-on expertise with High-speed ASIC SerDes technology and interconnects; SerDes IP (PAM-4, NRZ) characterization, product integration and certification.
$60 - $80 an hourExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Monitor the effectiveness of quality improvements and validation activities as part of the CAPA process requirements. + Minimum 1 year utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devices.
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Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
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The Quality Engineer is the key resource for the use of statistical techniques and validation activities (e.g. statistical process control, risk-based sampling, Gage R&R, Test Method Validation (TMV), DOE, process characterization, validation, and capability studies.
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Support the overall development of pharmaceutical biomanufacturing programs Execute system and process validation protocols Continually develop technical aptitude of PF's core capabilities including but not limited to: Project Management Cell and Gene Therapy Capital Projects Facility Builds Tech Transfers Validation Life Cycle Commissioning and Qualification Quality, Regulatory, and Compliance Engineering Automation and Serialization Reliability, Maintenance, and Asset Management.
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Hands-on mechanical and electrical assembly, testing for verification & validation (V&V) activities for prototypes and first articles. · Perform advanced design calculations and analyses to verify product performance, reliability, and regulatory compliance.
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Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
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Represent Manufacturing Compliance Engineer team on cross-functional teams involved in the design and implementation of new or updated quality systems in accordance with the corporate standards, regulatory standards, cGMP, and industry standards.
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The Packaging Engineer Manager is responsible for managing all aspects of the design, development, and validation of packages and packaging systems for medical devices at Tissue Technologies division of Integra, in compliance with applicable FDA and ISO requirements.
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Frequent contact with client auditors and regulatory representatives (e.g. FDA, DEA) for inspections, questions related to validation matters as required by the Validation Manager.
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This individual is responsible for providing departmental technical expertise for package development while collaborating with regulatory, marketing, market research, supply chain, process excellence and other affiliated departments and organizations to identify and address packaging needs.
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Responsible for all aspects of product design including - systems architecture, electrical engineering design, component selection, embedded systems / microprocessor based design and programing, requirements documentation, design verification, design validation, regulatory compliance, test plan creation, test tools and test scripts development, DFM/DFT, design reviews, and DFMEA. Lead projects ranging from short-term technology investigations to full-scale product development.
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You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.
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