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Akkodis is hiring an Onsite Quality/ Validation Engineer for a client in the Medical Device Manufacturing industry located in Bloomington, IN. You will serve as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. Must have's experience: Validation, remediation, NPI.
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This position is responsible for the development, application, and maintenance of quality requirements/standards under the direct supervision of the Quality Engineer Manager.
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Additionally, as a key member of our cross-functional team, you will contribute to constructing, evaluating, and appraising the outcomes of product development, encompassing user needs, design and development plans, usability, requirements, design documentation, risk management files, and verification and validation artifacts.
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Responsible for the development of tracking and trending systems for quality information including Nonconforming material (NCR’s), Product Returns (RGA’s), customer complaints and calibration.
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The Senior Design and Quality Engineer will be responsible for various quality functions in support of product development for Medical Contract Manufacturing, tasks will include leading Risk Management activities, collaborating within Instrument Technology, Inc. (ITI) and to our customers throughout the product life cycle, mentoring team members, and ensuring compliance with the Quality Management System (QMS.
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Project Engineering: The Senior Quality Engineer performs varied technical tasks which are non‑routine such as product improvement studies, process improvement studies, and development of new systems & procedures.
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Work with cross-functional teams (e.g.: R&D, Operations, Manufacturing Engineering, Service and Support, Product Management, Business Development, QA, QC, Regulatory Affairs) to drive resolution for internal issues/projects.
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Serve as primary point of contact for the Technical Writer in review and development of instruction manuals, revisions to artwork, and competitor product compatibility, when necessary, as new products are developed.
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The scope of influence of this position spans manufacturing, engineering, product development, plant warehouses, and sales branches. Responsible for the deployment of a Quality System including the development and oversight of the Pella Warehouse annual quality plan.
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The Senior Design Quality Engineer will be instrumental in driving the quality assurance aspects of product design and development, from concept through to market release.
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Support the development and implementation of quality improvement initiatives, such as lean manufacturing, Six Sigma, and root cause analysis to enhance product quality. Identify potential risks to product quality and customer satisfaction.
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The Principal Design Quality Engineer will be a key member of the Product Development team and will have the opportunity to influence the product design direction based on the customer’s needs and product reliability expectations and performance.
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The QA Analyst role plays an important part in our company’s product development process. We are looking for a Quality Assurance (QA) Analyst to develop and execute exploratory and automated tests to ensure product quality.
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Participate in new product development, focusing on quality planning and validation. As a Global Quality Assurance Engineer, you will spearhead quality assurance efforts, ensuring product and process excellence across our manufacturing sites.
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Assists with product development and its impact on the QMS. · 4-year degree in Science, Math or Engineering; or a 2-year degree with 3 years of experience in quality systems required.
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product development jobs Title: quality engineer in New York, NY
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