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ISO quality systems and / or responsibilities. Embark on a career articulating OEM and tier 1 aerospace manufacturers cleaning process utilizing Brulin’s chemistries and solutions to recalibrate their quality standards and captures savings for themselves.
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Plan, develop, maintain and report on all activities related to Quality Management System, including internal, and third-party audits, including such things as ISO certifications. Working knowledge of or proficiency with ERP systems (P21), SolidWorks, CMMs, or optical comparators is preferred.
$60,000 - $75,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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ISO-9001 Management Quality System. The QE will be a principal player in preparing HSI for ISO-9001 certification. Human Systems Integration, Inc. (HSI) of East Walpole, MA, is a leader in the development and production of high-tech wearable solutions.
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Monitor and audit Supplier quality management systems (ISO, IATF, AS9100, etc) 5+ years of relevant work experience as a Supplier Development Engineer, Supplier Quality Engineer, or in another engineering role responsible for developing, managing and improving supplier relationships, processes and efficiencies.
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Expert in Design Controls and compliance to FDA, cGMP, ISO, ASTM, MDD, and MDR requirements. Develop inspection and sampling plans, test methods, and measurement systems (capability, MSA/gage R&R, etc.
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Experience with cGMP purchasing practices, ISO, and medical device manufacturing. Essential Duties and Responsibilities: Packages unreleased components following written instruction provided by Quality/Engineering.
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The Electro-Mechanical Technician will prepare and assemble electro-mechanical and fluidic systems per Standard Operating Procedures (SOPs), Test methods (TMs), Protocols or Engineering Requests to support Operations, R&D and Quality Department.
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International Organization for Standardization (ISO) 9001 Lead Auditor Certification or an equivalent certification such as the American Society for Quality, Certified Quality Auditor Certification (CQA) within 3 years of start date.
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Other certifications or specialized training related to quality management systems - ISO standards - 9001, 20000 and 27000 and CMMI v3.0 DEV Level 3. Responsible for the oversight of the integrated QMS (Quality Management System.
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Preferences:In addition to meeting the basic requirements, the most successful candidate will also have:Moderate manufacturing experience in industrial engineering or scientific discipline;A background in automation with a working knowledge of Allen Bradley systems;Experience with GMP, ISO, and AS9100 quality system methods.
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Experience with gages, calibration, blueprint reading, and ERP systems is a plus. -Support CAPA process for Quality Department. -Assist in document control as required by ISO/IATF.
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Preferred: Previous experience with Lean Manufacturing and ISO/BRC quality systems. Additionally, this role demonstrates leadership in Continuous Improvement, ISO/BRC quality systems, innovation, safety, and leveraging current systems technology.
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Experience working in a company operating under ISO, FDA, or similar quality systems or regulations. Technical Certificate as an Electro-Mechanical Technician, Industrial Maintenance.
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Quality Control Knowledge: In-depth knowledge of quality and regulatory standards and guidelines such as ISO, FDA, and GMP. Specific industry knowledge in food/restaurant, computer equipment, and/or metal and sheet metal fabrication is a plus.
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Previous Co-op experience in Quality Assurance within an FDA, ISO or other regulated environment preferred. They will interface with other Insulet departments (e.g., varying levels of Management, Systems Engineering, Software Engineering, Design Verification and Regulatory Affairs) as well as other functional teams on initiatives related to product development and lifecycle/sustaining project support.
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