Quality Assurance Inspector

2 weeks ago

Minneapolis, Minnesota, United States Saluda Medical Full time
Job Overview

Salary: Competitive

Saluda Medical is a pioneering healthcare organization that is transforming Spinal Cord Stimulation (SCS) therapy through cutting-edge AI, real-time diagnostics, and innovative clinical evidence. Our mission is to enhance human health and streamline clinician operations by harnessing the potential of data and science to assist patients in need.

At Saluda, we push the limits of innovation. Our dedicated team of experienced professionals is committed to redefining the standard of care in the neuromodulation sector, aiming to improve the lives of individuals enduring chronic pain.

Position Summary: The Quality Control (QC) Inspector will report directly to the Director of Quality. This role is essential for conducting quality control assessments and evaluations to ensure that products meet the required standards for distribution.

Key Responsibilities:

  • Conduct quality control inspections following established quality system procedures.
  • Analyze manufacturing results, including sterilization parameters and test outcomes, while identifying any nonconformities.
  • Complete necessary documentation in line with Good Documentation Practices to accurately record inspection results.
  • Work collaboratively with Engineers and Supply Chain teams to address and manage nonconformities, supporting the resolution process.
  • Oversee microbial testing of products, including sampling, in accordance with set procedures.
  • Adhere to relevant regulatory standards, including FDA, EU, and TGA Regulations, as well as Saluda's Quality Management System.
  • Engage in internal and external audits of Saluda processes to ensure compliance with established protocols.

Essential Qualifications:

  • A minimum of 5 years of experience in the medical device sector or a similarly regulated field.
  • Proven attention to detail and accuracy.
  • Strong verbal and written communication skills, capable of interacting with various organizational levels.
  • Willingness to work on-site at the designated location five days a week.

Preferred Qualifications:

  • Familiarity with ISO 13485 and 21CFR 820 standards.
  • Training in LEAN manufacturing principles.
  • Experience in conducting Product Microbial Testing.

Saluda Medical values diversity and equal opportunity. We are dedicated to creating a team that reflects a wide range of backgrounds, perspectives, and skills, as we believe that our people are the foundation of our inspiration and innovation.

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