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Engineer, Quality Microbiology in Glens Falls, NY at Angiodynamics, Inc.

Date Posted: 3/2/2018

Job Snapshot

Job Description

Supports plant environmental systems and product monitoring programs. 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.I. Programs:
A. Plant Systems:
1. Assists in the planning and maintenance of the following systems:
  • Ambient & surface microbials
  • Ambient particulates
  • These programs assess the quality of the subject systems and take the necessary measures to assure control.
2. Serves as the QA representative in matters of plant systems. This includes not only the programs listed in a., above, but also:
  • controlled area design, maintenance and use
B. Product Monitoring:
1. Assists in the scope, planning, and maintenance of the following:
  • product bioburden
  • product bacterial endotoxins
II. Product Qualification:
  1. Biocompatibility, Sterilization, and Microbiological Assessment:
1. Responsible for Biocompatibility Assessments and Reports to evaluate new or
changed devices, components, materials or packaging with respect to biocompatibility, Bioburden, Endotoxin, sterilization lethality, and Ethylene Oxide Residuals.

III. Sterilization:
A. Routine Control and Release:
1. Support day to day sterilization operations. This task is achieved via document review, contractor and laboratory contacts, product inspection and testing and corrective actions/follow-up.

IV. Auditing/Regulatory Compliance:
A. Serves as a plant resource for:
1. Consultant in interpretation of ISO/FDA/AAMI regulations related to biocompatibility/microbiology.
2. Procedure generation/modification.

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

May perform other duties as assigned by supervisor
Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.