Quality Assurance Specialist

7 days ago


Plano, Texas, United States Bimini Health Tech Full time
Job Summary

We are seeking a highly skilled Quality Engineer to join our team at Bimini Health Tech. As a Quality Engineer, you will play a critical role in ensuring the development, implementation, and maintenance of our Quality Management Systems (QMS) and compliance with established standards and agency guidelines.

Key Responsibilities
  • Document Control and Quality Record Management: Develop and maintain the document control system, post market surveillance system, CAPA system, NCMR system, supplier maintenance programs, and quality engineering policies, processes, procedures, and controls.
  • Audits and Compliance: Conduct audits of internal and supplier processes, and ensure compliance with regulatory requirements, including FDA 21 CFR Part 820, 2017/745, and ISO 13485:2016.
  • Corrective Action and Preventative Action (CAPA) Management: Manage CAPA and CARs, and ensure timely resolution of quality issues.
  • Supplier Qualification and Follow-up: Qualify and manage suppliers, and ensure they meet our quality standards.
  • Training and Development: Develop and maintain the QMS Training program, and ensure all employees are trained on quality procedures and policies.
  • Recalls and Field Actions: Lead product recalls and field actions, as necessary.
Requirements
  • Education: Bachelor's degree in Engineering.
  • Skills: Strong technical writing and reading skills, knowledge of FDA medical device regulations, and experience with quality management systems.
  • Experience: Demonstrated success in Medical Device Quality Engineering, knowledge of quality regulations, and statistical analysis and problem-solving ability.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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