Quality Assurance Specialist


Quality Assurance Specialist

@ Tides Medical


  • The Quality Assurance Specialist will collaborate with various stakeholders to develop, implement, and maintain the Quality Management System and its platform.
  • The QA Specialist will ensure documentation has been properly developed, execute risk assessments, corrective actions/preventive actions, support audits. 

Essential Functions of the Areas of Responsibility

  • Evaluate adequacy of technical documentation per cGMP, ISO, FDA, and AATB. 
  • Initiate, and support the execution and completion of investigations associated with material/product specifications and deviations. 
  • Evaluate material/ product non-conformances to identify and assess root cause. 
  • Interface with impacted departments to identify and evaluate risk associated with product impact. 
  • Participate in meetings/projects as required (non-conformances, problem solving, team meetings). 
  • Participate in process improvement teams and/or completes relative documentation when required. 
  • Support quality manager in suggesting or communicating ideas for continuous improvement to maximize product quality, efficiency, and minimize costs. 
  • Support compliance with established practices, polices, established to meet compliance with all applicable laws and regulations.
  • Support the management of risk assessments that pertain to or impact material and/or regulatory requirements. 



  • General understanding of global medical device and tissue product regulations with experience with ISO 13485 and/or 21 CFR Parts 820 
  • Minimum of 2 - 4 years’ experience with technical documentation for quality activities, such as corrective actions quality audits, and validation of manufacturing processes, or product development in an FDA regulated medical device and tissue environment. 
  • Strong organizational and planning skills. 
  • Be self-motivated, attentive to details and able to prioritize and meet deadlines. 
  • Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with stakeholders.

How to Apply:

Apply online at https://www.tidesmedical.com/careers/ 

Visit Site to Apply

Location: Lafayette, LA
Date Posted: May 17, 2023
Application Deadline: June 20, 2023
Job Type: Full-time