Quality Engineer III
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Location
In office (Cartago)
Seniority
Middle
Overview
Company
Impact
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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...
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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