Post-Market Quality Assurance Specialist

24 hours ago


Minneapolis, Minnesota, United States Saluda Medical Full time
Job Title: Post-Market Quality EngineerJob Summary

Saluda Medical is seeking a highly skilled Post-Market Quality Engineer to join our team in Minnesota. As a key member of our quality team, you will be responsible for analyzing medical devices, conducting thorough investigations, and assessing risk associated with reported events.

Key Responsibilities
  • Investigate complaints by evaluating returned products to determine the cause and assess the risk.
  • Develop and maintain expertise in product performance, design, development, and manufacturing improvement activities.
  • Prepare and contribute to product trending reports to ensure Saluda Medical products continue to perform safely and effectively.
  • Support quality initiatives, including CAPAs, by assisting in the investigation and implementation of corrective actions.
  • Identify process improvement opportunities and participate in projects to enhance efficiency and robustness of complaint processes.
  • Perform decontamination of returned products prior to evaluation.
  • Collaborate with external suppliers to ensure timely review and analysis of returned products.
Requirements
  • Bachelor's degree or higher in Materials Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.
  • 2+ years' experience in the medical device industry or other regulated industry.
  • Experience with electro-mechanical devices.
  • Demonstrated strong attention to detail and ability to work on-site at Saluda Medical's Minnesota site and laboratory.
What We Offer

As a Post-Market Quality Engineer at Saluda Medical, you will have the opportunity to work with a pioneering company in the field of closed-loop Spinal Cord Stimulation (SCS). Our team is dedicated to delivering innovative solutions that improve patient outcomes, and we are committed to fostering a collaborative and inclusive work environment.



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