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Quality Assurance Specialist

2 months ago

Bloomington Indiana, United States Cook Group Full time
Job Summary

Cook Group is seeking a highly skilled Quality Engineer to lead our product development and manufacturing efforts. As a key member of our quality team, you will be responsible for ensuring the highest level of quality in our products.

Key Responsibilities
  • Quality Leadership: Provide strategic direction and guidance on quality-related matters to ensure compliance with regulatory requirements and company standards.
  • Product Development: Collaborate with cross-functional teams to develop and implement quality plans, processes, and procedures for new products.
  • Manufacturing Support: Work closely with manufacturing teams to ensure the quality of products and identify areas for improvement.
  • Regulatory Compliance: Ensure that all products meet regulatory requirements and industry standards.
  • Continuous Improvement: Drive continuous improvement initiatives to enhance quality processes and reduce defects.
Requirements
  • Education: Bachelor's degree in Engineering or a related field.
  • Experience: Minimum 5 years of experience in quality engineering or a related field.
  • Skills: Strong knowledge of medical device regulations (ISO 13485, 21CFR) and risk management (ISO 14971). Proficiency in statistical, quality, and continuous improvement methods and tools.
  • Certifications: Professional certification (e.g. ASQ, Six Sigma) preferred.
Working Conditions

This role requires working in a fast-paced environment with frequent interactions with cross-functional teams. The ideal candidate will have strong communication and interpersonal skills, with the ability to work effectively in a team environment.