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Quality Assurance Specialist

2 months 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 risk assessments and implement mitigation strategies to ensure compliance with regulatory requirements.
  • Analyze and summarize quality data to identify trends and areas for improvement.
  • Collaborate with cross-functional teams to ensure quality and compliance throughout the product lifecycle.
  • Lead root cause analysis and corrective action initiatives to resolve quality issues.
  • Manage supplier quality and process improvement data to ensure compliance with customer requirements.
  • Develop and oversee incoming inspection processes to ensure quality and compliance.
  • Lead QA efforts with suppliers and handle nonconforming material to ensure quality and compliance.
  • Investigate and resolve product complaints to ensure customer satisfaction.

Requirements:

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