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Years’ of diverse experience in high volume production setting Hands-on electro-mechanical repair, rebuild, field service experience Familiarity with formal preventative maintenance program Experience working in a company operating under ISO, FDA, or similar quality systems or regulations COMPETENCIES: Skill in using computer applications including spreadsheet, database, and word processing software.
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Experience working in a company operating under ISO, FDA, or similar quality systems or regulations. Technical Certificate as a Electro-Mechanical Technician, Industrial Maintenance Technician or a Technical Degree in Precision Machining and Manufacturing, Automotive Repair, or related technical field.
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Technical Certificate as a Electro-Mechanical Technician, Industrial Maintenance Technician or a Technical Degree in Precision Machining and Manufacturing, Automotive Repair, Hands-on electro-mechanical repair, rebuild, field service experience.
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Experience working in a GMP, FDA, ISO, and USDA regulated environment preferred. Job Summary: Responsible for supporting product development from concept through sustained manufacturing of FDA regulated products.
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Experience working in a GMP, FDA, ISO and USDA regulated environment. Our location in Westbrook, Maine currently has an opportunity for a Manufacturing Engineer II. In this role you will be responsible for supporting product development from concept through sustained manufacturing of FDA regulated products.
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In this role you will be responsible for supporting product development from concept through sustained manufacturing of FDA regulated products. The position of Manufacturing Engineer II is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine.
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Robots (Staubli and/or Epson experience preferred)Ability to modify robot programs and taught positions. Human Machine Interfaces (HMI) (Allen-Bradley Factory Talk View experienceAbility to modify and troubleshoot existing user interfaces.
$57,300 - $114,700 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements. Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
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Bachelor's degree (BS) in engineering or equivalent combination of education and experience. Minimum 3 years engineering experience in a manufacturing environment.
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Familiarity with statistical analysis software (Minitab). Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation.
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Knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; MS Excel software and MS Word software. Initiates and works to resolve Quality Incidents and CAPA.
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Maintain area compliance per FDA, ISO and OSHA requirements. Assist Supervisor/Manager in troubleshooting and other projects as necessary. Maintain area compliance per FDA, ISO and OSHA requirements.
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Support production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.
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Technical Certificate as an Electro-Mechanical Technician, Industrial Maintenance. Technician or a Technical Degree in Precision Machining and Manufacturing, Automotive. Skill in using computer applications including spreadsheet, database, and word processing software.
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2+ years’ experience with GMP, FDA, ISO and USDA regulations. Knowledge of enzyme and/or immunochromatographic assays, inspection/measurement systems, systematic troubleshooting, statistics and data analysis.
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iso fda jobs in Westbrook, ME
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