Quality Assurance Specialist

3 weeks ago


Arkansas, United States ACE Partners Full time
Quality Engineer Job Description

We are seeking a highly skilled Quality Engineer to join our team at ACE Partners. As a Quality Engineer, you will play a critical role in ensuring the quality and compliance of our medical devices.

Key Responsibilities:

  • Develop and implement quality improvement initiatives to enhance our products and processes.
  • Conduct thorough quality audits and assessments to ensure compliance with ISO 13485, FDA QSR, and GMP regulations.
  • Analyze data and prepare quality reports to identify trends and areas for improvement.
  • Collaborate with cross-functional teams to resolve quality-related issues and implement corrective actions.
  • Develop and maintain quality control processes and procedures to ensure consistency and accuracy.
  • Lead supplier quality assessments and develop strategies to improve supplier performance.
  • Investigate and resolve product complaints in a timely and efficient manner.

Requirements:

  • Proficient in Microsoft Office and quality management software.
  • Strong communication and organizational skills with the ability to work independently and as part of a team.
  • BS in Engineering (or equivalent) with 3+ years of experience in medical device quality assurance.
  • Deep knowledge of ISO 13485, FDA QSR, and GMP regulations.

What We Offer:

A competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.



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