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As Associate Director/ Director, Quality Engineering, you are accountable for the Development, Execution and Delivery of domestic and international Quality Strategies for Energy Based Devices at Merz Aesthetics.
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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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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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DHR Review: Document review, SAP transfer review, variance review and submission to quality. Typically requires bachelor's degree in Microbiology, Biology, Chemistry, Chemical Engineering or related field.
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Provide in all phases of capital projects; (e.g. ensure project complies with site standards, practices and goals) power study reviews, specification reviews, participation in HAZOP/DHR, provide alternative selection/options with multiple solutions.
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Overseeing our 3D printing and machine shop, you will be responsible for working closely with our engineering team to provide exceptional services and solutions for our clients. Maintain accurate records to ensure Device History Records (DHR) and quality documents are accurate when required.
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The Senior Quality Engineer is responsible for providing quality engineering support for manufacturing on a day-to-day basis to ensure regulatory compliance. · Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process.
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PRIMARY DUTIES AND RESPONSIBILITIES (List of 8 # 10 key tasks required of the job which are essential to the performance of this job) Cross Functional Team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline.
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May develop, evaluate, implement and maintain technical quality assurance and control systems and standards pertaining to materials, techniques, or company products including ensuring a thorough connection between design controls deliverables (from design planning, requirements development, risk management, design verification/ validation through design transfer) in the DHF to process validation, production and process controls and content captured in the DHR.
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Generates required documentation to complete the Device History Record (DHR) Requires an Bachelor's degree (B.S.) in Mechanical or Electrical engineering field. Tech 1, Mechanical Engineering.
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Medical device,New product development,Solidworks,Design,Mechanical engineering,R&d,Research & development,Design control,Validation,Design History Record,DHR,Design change. Medical device, New product development, Solidworks, Design, Mechanical engineering, R&d, Research & development, Design control, Validation, Design History Record, DHR, Design change.
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Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling, etc. Cross Functional Team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline.
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Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements.
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Specific functional areas include, but are not limited to, contract review, job shop process/paperwork preparation, and technical and engineering support. Creation and maintenance of internal/external files required for product realization as applicable within the shop software (E2) and Windows environment (DMR/DHR.
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The principles and practices of general civil engineering; engineering mathematics; engineering mechanics and the mechanics of materials; principles and practices of topographic surveying; structural, mechanical, electrical, hydraulic, hydrologic, and sanitary engineering principles and practices to the extent these apply to the general field of civil engineering.
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