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Compile and document investigation, repair and test results in paperless device history record and ensure compliance with QSR/ISO requirements. Compile and document investigation, repair and test results in paperless device history record and ensure compliance with QSR/ISO requirements.
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The Production Operator works as part of the manufacturing line assembling medical device components, performing label printing and packaging functions, and operating machinery, in a FDA regulated production environment.
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Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA Regulations. 1 or more years assembler experience in the medical device field or a related technical field.
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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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Requirements: Knowledge of FDA’s Quality System Regulation (QSR) and the changing EU Medical Device Regulation (MDR) is required. Review/participates in preparing design history file documentation, including verification/validation testing, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling.
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Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing. Substantial knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations.
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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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This is a collaborative position working closely with Operations to support production management and production initiatives while ensur ing compliance with AVIs Q uality Management System (QM S ) and FDA Quality System Regulation ( QSR ) requirements.
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Support production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements.
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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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Must have a expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc. Ensures complete and correct Device History Records are maintained through DHR review and periodic audits.
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Working knowledge and understanding of QSR, ISO (13485), FDA and EU MDR and other medical device industry quality requirements. Medcura, Inc. is an innovative medical device company dedicated to advancing wound care solutions that improve patient outcomes and reduce healthcare costs.
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Experience working within a rigorous quality system environment (ISO, FDA cGMP/QSR, risk management, regulatory affairs, design control) The Sr. Director of Global Product Experience is responsible for leading Solta's Global product experience and technical service operations in accordance with both FDA QSR guidelines, Solta's quality policy, and defined commercial business objectives.
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Familiarity of medical device quality systems (QSR) related to regulatory activities. 5 plus years' Regulatory Affairs / Quality Assurance experience within an FDA regulated medical device industry.
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Responsible for day-to- day compliance and adherence to FDA QSR requirements. Minimum of 4 years combined industry (biomedical, medical device) and/or military experience; or 6 years of combined industry, military and/or related (general manufacturing, quality or logistics) experience.
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