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A Bachelor’s or Associate degree is a plusMinimum 3 years supervisory experience; 5 years of experience in a production environmentBasic PC skills including Microsoft Office, specifically Microsoft Excel and PowerPointExperience in material control, production control and quality control processesExperience working in the medical device industry (ISO, GMP, FDA, QSR, etc.
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Support production on the manufacturing floor, ensuring adherence to procedures and ensuring appropriate device history record (DHR) documentation. Working knowledge of FDA, cGMPs/QSR, and ISO quality system requirements.
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Support production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
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Req ID: 42117 Job Category: Quality Plymouth, MN, US, 55447 Nearest Major Market: Minneapolis Job Segment: Senior Quality Engineer, Quality Engineer, Medical Device Engineer, Manufacturing Engineer, Infection Control, Engineering, Healthcare STERIS Corporation is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Administers the non-conforming material system through processing NCMR's physical segregation and labeling material, transacting in the operating sysand filing of associated quality records per ISO/Quality System Regulation (QSR) requirements.
$19.5 - $20.5 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Facilities Engineer also implements commissioning and startup activities and maintains facilities related QSR documentation. Bachelor’s degree in Industrial Engineering, Mechanical Engineering, or a closely related field of study with 2 years of experience in facilities and project documentation in the pharmaceutical or medical device industries.
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Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations. Mastery in one or more key process areas: automation, medical-device assembly, controls, etc. 10 years' experience in the Medical Device or Engineering Industry.
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Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines), and ensure compliance with testing SOPs and specifications. Must know operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs.
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Has awareness of device defects that may occur in their area of responsibility, including product design, verification, validation, manufacturing, and testing activities. The position of Manufacturing Line Quality Engineer is within the Infectious Disease Developed Markets business unit located in Westbrook, Maine.
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Experience with Medical Product verification and FDA Quality Systems Regulations (QSR) on complex medical device. Experience as a software verification engineer leading all phases of development of a medical device from concept phase, proof of design testing, development testing, SW release and maintenance.
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Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines is required. Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device manufacturing.
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5+ years of Quality Assurance experience in a QSR (GMP), disposable medical device environment. Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
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Ability to follow detailed instructions, maintain accurate records, complete assignments in a thorough, conscientious fashion while adhering to company procedures and QSR compliance. The scope of this role is responsible for carrying out the daily operations of the Change Management function as it pertains to product labeling, design control projects and device master records maintenance.
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Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations. Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR.
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Experience w/ GMP, QSR, SPC, ISO standards in medical device environment ideal. Six Sigma and/or Lean manufacturing certifications ideal (green belt / black belt etc) Communicate customer requirements & product specs to manufacturing thru BOM & router entry.
$85,000 - $115,000Full-timeExpandApply NowActive JobUpdated 4 days ago
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