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Biomedical Search Consultants
Published
February 26, 2024
Location
Rochester, NH
Category
Job Type

Description

Our client, a medical device contract manufacturing company, has an immediate opening for a Quality Engineer. This role will support the Quality Management System (QMS) to ensure compliance to the regulatory and procedural requirements in the manufacture of disposable medical products for customers.

Responsibilities:

  • Understand and ensure compliance to the ISO 13485:2016, 21 CFR Section 820, MDD, and Quality System requirements
  • Act as the quality interface for assigned customers and suppliers
  • Monitor customer complaints and trends. Respond as needed for failure investigation and specific corrective actions
  • Provide quality support to existing product/process issues, including NCMR’s, MRB, root cause analysis, Deviations, test procedures, and protocols
  • Conduct risk analysis for products and processes being transferred, following guidance under ISO 14971
  • Create Quality Plans and Master Validation Plans in support of customer product implementation
  • Develop verification and validation protocols supporting the implementation of products and processes into clean room production environments
  • Manage customer deliverables and quality documents to an approved/released state
  • Perform/participate in audits of suppliers as required
  • Coordinate efforts with Engineering and Manufacturing for the establishment of controls, which support current product designs and process capabilities for assigned product lines
  • Lead product, process, and component root cause failure analysis with Engineering counterpart
  • Drive the CAPA process to completion on assigned corrective and preventive actions
  • Other responsibilities as required

Requirements:

  • Comprehensive understanding of ISO 13485:2016 and FDA Quality System Regulations (QSR) under 21CFR Sec. 820 as they pertain to the production of medical devices
  • Comprehensive understanding of EEC Medical Device Directives and any necessary product-specific applicable standards
  • Complete understanding of ISO 14971 Risk and Hazard Assessment
  • Strong statistical analysis skills with ability to analyze and interpret data utilizing Minitab software
  • Ability to conduct Root Cause Analysis using Fishbone Diagrams and/or Fault Tree Analysis
  • Must possess strong written and verbal communications skills
  • Competent in Microsoft Office Suite, including Word, Excel, Power Point, and Visio
  • Good presentation and training skills
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