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Quality Assurance Engineer for Post-Market Analysis

2 months ago

Bloomington, United States Saluda Medical Full time

Company Overview: Saluda Medical is at the forefront of innovation in closed-loop Spinal Cord Stimulation (SCS), offering a revolutionary therapy that dynamically adjusts based on real-time feedback from the spinal cord. With a global presence, Saluda Medical operates from its headquarters in Australia and has additional offices in the United States and Europe.

Position Summary: The Quality Assurance Engineer focusing on post-market analysis plays a critical role in evaluating Saluda medical devices. This position involves conducting thorough investigations, analyzing reported incidents, monitoring product performance trends, and ensuring the effective operation of the returned product analysis laboratory at the Minnesota facility.

Key Responsibilities:

  • Lead investigations into product complaints by assessing returned items to validate reported issues, identify root causes, and evaluate associated risks.
  • Develop expertise in product and procedural knowledge to contribute to insights regarding product performance and enhancements in design, development, and manufacturing processes.
  • Compile and present product performance trend reports and participate in cross-functional reviews to ensure the ongoing safety and efficacy of Saluda products.
  • Assist in quality improvement initiatives, including Corrective and Preventive Actions (CAPAs), by supporting investigations and the implementation of necessary corrective measures.
  • Identify opportunities for process enhancements and engage in projects aimed at increasing the efficiency and reliability of complaint handling procedures.
  • Conduct decontamination processes for returned products prior to detailed evaluations.
  • Collaborate with external suppliers to facilitate timely reviews and analyses of returned products manufactured for Saluda Medical.
Qualifications:
  • A Bachelor's degree or higher in Materials Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
  • A minimum of 2 years of experience in the medical device sector or a similarly regulated industry.
  • Familiarity with electro-mechanical devices.
  • Proven ability to maintain a high level of attention to detail to ensure comprehensive product analysis and accurate documentation of findings.
  • Willingness to work on-site at the Saluda Minnesota facility and laboratory.