Manufacturing Quality Engineer II — Drive Compliance & CI

Nextern; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Care Plan

Retirement Plan with Company Match

Paid Time Off

Personal Days

Birthday Holiday

Lifetime Membership Subsidy

Wellness Resources

Life Insurance

Family Leave

Disability (Short/Long)

Taco Thursdays

Job summary

Nextern is seeking a Manufacturing Quality Engineer in Minnesota to ensure programs meet quality, regulatory, and customer requirements. You will provide quality oversight, drive compliant execution, and support continuous improvement across the product lifecycle.

You will support development activities during launches, including manufacturing readiness, audits, and clinical builds, ensuring a smooth transition while maintaining accurate DHFs.

Qualifications

• Bachelor's degree in a life science discipline or equivalent.
• 5+ years in medical device development/manufacturing, or 3+ years in design assurance or quality engineering.
• Experience with 21 CFR Part 820 and ISO 13485.
• Demonstrated leadership in quality and strong attention to detail.
• Creative problem-solving and clear written/verbal communication.

Responsibilities

• Serve as a core team member for operations quality deliverables.
• Author and approve SOPs, work instructions, and forms; support internal audits.
• Trend quality metrics and drive corrective/preventive actions.
• Oversee incoming inspection and coordinate supplier corrective actions.
• Provide quality oversight for IQ/OQ/PQ activities and review change orders.
• Lead CAPAs from initiation through verification and root-cause analysis.
• Draft and approve product/engineering work orders and maintain DHFs.
• Advise project teams on Quality and Regulatory best practices; ensure documentation.

Skills

Quality leadership

Regulatory knowledge

Quality systems

Documentation

Attention to detail

Communication

Education

Bachelor's degree in life science

Job description

Nextern is seeking a Manufacturing Quality Engineer in Minnesota to ensure programs meet quality, regulatory, and customer requirements. You will provide quality oversight, drive compliant execution, and support continuous improvement across the product lifecycle.

You will support development activities during launches, including manufacturing readiness, audits, and clinical builds, ensuring a smooth transition while maintaining accurate DHFs.