Quality Engineer III

Nextern • 4 days ago
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Location
In office (Cartago)
Seniority
Middle
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Nextern

Nextern, Inc., is located in St. Paul, MN and Nextern Technical Products has multiple locations in China. Nextern is a vertically integrated cGMP design and global manufacturing company creating non-invasive solutions to improve personal health, w...
nextern.com • Ho Chi Minh City • Naypyidaw • Cartago • Ben Cat • Maple Grove • Health & Medical Electronics • Health Care • Medical Devices

We are looking for a Quality Engineer III to support and lead quality activities in manufacturing and new product transfers to production. This role works closely with cross-functional teams and customers to ensure proper implementation of quality standards, validations, and manufacturing processes within a regulated environment.

Key Responsibilities

  • Lead quality activities related to manufacturing and new product introduction/transfer.
  • Execute validations, audits, and quality assessments to ensure process compliance.
  • Develop and improve manufacturing and inspection processes.
  • Collaborate with cross-functional teams and provide floor support during production ramp-up.
  • Prepare technical reports and support quality-related decisions.
  • Provide technical guidance and mentorship to junior engineers.

Requirements

  • Bachelor’s degree in engineering or related field.
  • 4 - 5 years of experience in quality engineering within manufacturing or regulated industries.
  • Experience with validations, audits, and new product transfer activities.
  • Strong communication and technical leadership skills.
  • Hands-on approach with shop-floor presence.
  • Catheter experience is required
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