Quality Assurance Specialist

4 weeks ago


Plano, Texas, United States Spark Life Solutions, Inc. Full time
Quality Engineer

At Spark Life Solutions, Inc., we are seeking a highly skilled Quality Engineer to join our team. This role will be responsible for ensuring the quality of our products and processes, while also collaborating with cross-functional teams to drive continuous improvement.

Key Responsibilities:
  • Establish and maintain a Quality Management System (QMS) that meets ISO 13485:2016 and 21 CFR 820 standards.
  • Collaborate with engineering, purchasing, and production teams to ensure customer and division quality requirements are met.
  • Provide guidance on Design Control and Risk Management activities to ensure regulatory compliance.
  • Facilitate risk management activities for products throughout the device lifecycle.
  • Review and approve design, manufacturing, and testing documentation.
  • Lead root cause failure investigations and product stability evaluations.
  • Conduct statistical analysis of data from experiments and manufacturing process trend monitoring.
  • Support Receiving/Inspection functions and create raw material specifications.
  • Project manage post-market surveillance activities and oversee inspection activities.
  • Formulate and maintain quality control standards and objectives.
  • Review and approve contractor and sub-contractor quality control documentation.
  • Ensure compliance with regulatory agency requirements and company policies.
Requirements:
  • 5+ years of experience in manufacturing functions within an engineering discipline.
  • Bachelor's degree in engineering or a related field.
  • Experience in new product development and introduction to manufacturing.
  • Experience in risk management and post-market surveillance.
  • Interaction with regulatory bodies (FDA ISO).
  • Medical device manufacturing experience is required.


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