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Quality Assurance Specialist

2 months ago


Austin, Texas, United States Select Source International Full time
Job Overview

We are seeking a dedicated Quality Assurance Specialist to ensure that our products meet the highest standards of quality and safety.

Key Responsibilities:

  • Establish comprehensive criteria for quality checks and standards.
  • Maintain and enhance our Quality Management System (QMS) by documenting incidents, resolutions, and enhancements.
  • Conduct audits in compliance with ISO 9001:2015 standards.
  • Define quality metrics applicable to all manufacturing processes.
  • Oversee the production cycle and execute routine testing to detect potential issues proactively.
  • Examine product materials and electrical components for flaws and resilience.

Qualifications:

  • Bachelor's degree in engineering (Mechanical, Biomedical, or a related discipline).
  • 2-5 years of experience in quality assurance within the medical device sector.
  • Familiarity with FDA regulations, ISO 13485, and other pertinent standards.
  • Strong analytical skills with a background in root cause analysis and Corrective and Preventive Actions (CAPA).
  • Expertise in quality methodologies and tools (e.g., FMEA, Six Sigma).
  • Exceptional communication and collaboration abilities.
About Select Source International

Select Source International (SSI) is a consulting firm specializing in IT, Health Care, and Engineering Services, established in 1998. Our team of consultants has consistently delivered outstanding services that have garnered appreciation from clients across various sectors, including Fortune 500 companies and mid-sized enterprises.