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Finish Line Staffing Services
Published
September 23, 2022
Location
Billerica, MA
Category
Job Type

Description

Our client, a medical device innovator, has an immediate need for a Sterilization Quality Engineer (SQE).  The SQE is responsible for ensuring continued compliance of the Quality System with quality standards for medical devices, including but not limited to assuring that the Microbiology/Sterilization function is maintained per industry standards and maintaining and upgrading the quality system to meet QSR and ISO13485 requirements.

Responsibilities:

  • Develop and maintain strong internal working relationships across the company.
  • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
  • Prioritize and plan work activities; adapt for changing conditions.
  • Perform validations, revalidations, and continuous improvement on sterilization processes (Sustainability projects) in accordance to industry and regulatory standards. This includes EO, VHP, and Gamma sterilization modalities
  • Support all activities relating to sterilization. This includes authoring protocols and reports, running test cycles, authoring work instructions, and interpretation of test results.
  • Support all activities relating to Environmental Monitoring program. This includes but not limited to, performing viable and non-viable counts for ISO classified cleanrooms, RODI water testing – Bioburden, TOC, Conductivity, and Endotoxin, reviewing, and reporting trends.
  • Develop and upgrade Microbiology/sterilization procedures for continuous improvement as required by the quality system.
  • Assist with, review protocols/reports, and/or conduct sterile barrier packaging validations.
  • Participate and/or conduct product and process Out of Specification (OOS) and corrective and preventive action (CAPA) Investigations from issue identification, deviation development through product disposition
  • Implement and maintain quality system in accordance to applicable regulatory requirements.
  • Be familiar with microbiology testing equipment, operation and maintenance – this will include Bioburden, Sterility, and Endotoxin test equipment
  • Other responsibilities as assigned.

Requirements:

  • Bachelor’s Degree in scientific field, preferably microbiology
  • 2+ years of QA experience preferably in a medical device company.
  • Experience in sterilization process management including validation
  • Experience validating water systems and clean rooms
  • Extensive and comprehensive understanding of FDA regulations.
  • Extensive and comprehensive understanding of the ISO 13485 certification process and requirements.
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