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
Skills Required
- Bachelor's degree in engineering or a related field
- 4–5 years of quality engineering experience 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
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
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