We are looking for a Sr Quality Engineer 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+ 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.
Skills Required
- Bachelor's degree in Engineering or related field
- 4+ 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
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.
