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Quality System Engineer

  • Date Posted January 13, 2020
  • Location Bedford, MA
  • Job Type Contract To Hire
  • Job ID 14850

Quality System Engineer- Boston, MA

Our Boston-based Medical Device client is developing scientific products that allow physicians to make evidence-based decisions. They are currently growing and looking to hire a Quality System Engineer whowould have the following responsibilities:

Responsibilities:

  • Responsible for activities required to ensure compliance of companies' Quality Management Systems (QMS), specifically regarding Customer Complaints.
  • Support other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc.
  • Gather information necessary to conduct thorough and accurate complaint investigations, including additional event information/descriptions, Good Faith Efforts (GFE's), and patient status information.
  • Product status and return authorizations.
  • Execution and coordination of activities associated with the company complaints process, including complaint administration and record management, investigations, reporting, as well as metrics and trending.
  • Coordinate with the cross-functional team where necessary
  • Perform risk assessments utilizing released product risk documentation such as PFMEAs and UFMEAs.
  • Use a data-driven approach to the decision-making process, including evaluation of product performance.
  • Make reportability decisions promptly to ensure compliance with FDA regulations.
  • Write customer letters to inform users about Best Practices or Instructions for Use as needed.
  • Support field actions and other post-market surveillance activities when required.
  • Support the company business as a subject matter expert concerning investigation tools and techniques, statistical analysis, as well as proper documentation practices.
  • Identify opportunities for improvement within the Quality System to ensure compliance and efficiency.
  • Support work on quality plans, quality processes, and special projects, as required.

Minimum Requirements:

  • Bachelors in Engineering, Biomedical Science, or technical degree preferred
  • 2-3 years of relevant experience in the medical device industry.
  • Knowledge of Quality System Standards and regulations including ISO 9001, ISO 13485, and QSR
  • Experience in operational quality function within a device manufacturing environment strongly preferred
  • Strong written/verbal communication and project management skills
  • Strong analytical, deductive reasoning and listening skills
  • Experience in the creation and documentation of procedures and processes
  • Must be able to communicate precisely and accurately to all levels of the organization
  • Proficiency with Microsoft Office – Word, Excel, PowerPoint, and Access experience required

If interested, please contact Earl Callender at ecallender@daleyaa.com