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Engineer I, Quality Biocompatibility in Glens Falls, NY at Angiodynamics, Inc.

Date Posted: 5/8/2018

Job Snapshot

Job Description

Plans and directs activities concerned with the design, development, application, validation, implementation and maintenance of quality standards to ensure that new and existing products meet requirements for biocompatibility and microbiological safety.

Essential Duties and Responsibilities

  • Maintains a comprehensive understanding of global medical device regulations with respect to Biocompatibility, and by identifying and assessing emerging standards, theories and methodologies and applying gained expertise within the Biocompatibility processes.
  • Assessment of biocompatibility requirements for new or modified devices, or processes.
  • Generate protocols outlining required testing, coordinate building & sterilization of test articles, and communication with laboratory experts.
  • Generate biocompatibility reports which document the test results and an interpretation of the compliance of those results with the requirements.
  • Maintain a thorough understanding of all product families manufactured.
  • Communicate with regulatory agencies to advance product approvals, submission determinations, etc. as it pertains to biocompatibility and toxicology of medical devices.
  • Provide support and guidance within the global organization regarding regulatory compliance as it pertains to biocompatibility and toxicology issues associated with medical devices.
  • Develop and maintain open communication with all internal and external contacts.
  • May perform other duties as assigned

Regulatory Responsibilities

  • Manages in order to ensure compliance with all relevant regulatory/legal requirements

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

  • Individual Contributor - Build Quality into all aspects of their work by maintaining compliance to all quality requirements