Quality Assurance Engineer for Suppliers

2 weeks ago


Scarborough, Maine, United States The Fountain Group Full time

The Fountain Group is currently seeking a Supplier Quality Engineer for a prominent client. Below are the details for this role:

Position Overview:

  • Compensation: $40-$45/hour
  • Duration: 3-month assignment with potential for extension based on performance and budget considerations.
  • Work Schedule: Monday to Friday, 8 AM – 5 PM.
  • Key Responsibilities:
  • Oversee the Supplier Quality Function, collaborating closely with Purchasing and the New Product Development and Engineering teams.
  • Address internal and external supplier inquiries related to quality in a timely and professional manner.
  • Manage supplier modifications through the change management system.
  • Evaluate Supplier Validation Protocols to ensure compliance with regulatory and customer standards.
  • Coordinate with the engineering team to schedule and conduct first article inspections, capability studies, and gage R&Rs for purchased products.
  • Conduct root cause analysis for product quality issues and defects related to new and existing purchased products, implementing solutions to resolve these issues; assist other personnel with the Corrective Action process for purchased components and services as needed.
  • Oversee the Supplier corrective action process and drive improvements to the Approved Supplier List (ASL).
  • Identify and implement continuous improvement initiatives to enhance quality systems and processes.
  • Perform external audits as necessary, based on the established audit schedule or if suppliers are not meeting quality metrics.

Qualifications:

  • Bachelor's degree in Engineering, Manufacturing, Biology, or a related field, or an equivalent combination of education and experience is required.
  • A minimum of 1 year of experience in Quality or Supplier Engineering is required, preferably within the medical device sector.
  • Proficiency in Microsoft Word, PowerPoint, and Excel is essential.
  • Familiarity with federal regulations and standards, such as QSRs, ISO 13485, CMDR, IVDD/IVDR, is preferred. A working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures is also advantageous.


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