Senior Global QA Engineer — Medical Devices (GMP/ISO)

Nextern; Maple Grove (MN); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Health Plan (Medical, Dental & Vision)

Retirement Plan with Company Match

Paid Time Off, Personal Days, Birthday

Lifetime Membership Subsidy and WELL/}

Job summary

Nextern is seeking a Quality Engineer to oversee manufacturing and device quality for commercial devices at its global sites. The role focuses on sustaining activities, changes, audits, CAPAs, and complaint investigations under GMP/GDP and ISO 13485 frameworks.

Based on our Minnesota facility, the position requires hands-on quality leadership across global sites, collaboration with sustaining engineers, and proactive process improvements to ensure compliance and product quality throughout the

Qualifications

• 5+ years in medical device manufacturing quality
• Experience supporting global sites
• Compliance with 21 CFR 820 and ISO 13485
• Fluency with electromechanical terminology
• Understanding of ISO 14971 and risk management
• GMP, GDP expertise
• Leadership in quality and problem solving
• Strong communication and analytical skills
• Familiar with QC tools: nonconformance, CAPA, root cause
• Proficient with Minitab and PLM software

Responsibilities

• On-site at US facility, supporting Vietnam/Costa Rica sites up to 20%
• Receive, investigate and trend complaints
• Lead nonconformance investigations and CAPAs
• Summarize and present data to stakeholders
• Collaborate with sustaining engineers for improvements and audits
• Draft and approve project deliverables and work orders
• Review changes to parts and documentation
• Coordinate shipments between sites and customers
• Coordinate verification/validation testing
• Create and maintain Device Master Records (DMR)
• Own manufacturing/DHR review in root cause investigations
• Lead GMP/GDP practices
• Identify improvements in Quality System requirements
• Approve changes with documented impact and actions
• Support audits as SME for QMS processes
• Lead PLM architecture changes as needed

Skills

Quality experience

Global manufacturing

Regulatory compliance

GMP/GDP

Risk management

Leadership

Communication

Quality tools

Minitab

MS Office

PLM software

Windchill

Agile PLM

Propel

Electrical concepts

Education

Bachelor's Degree in engineering

Tools

Windchill

Agile PLM

Propel

Minitab

MS Office

Job description

Nextern is seeking a Quality Engineer to oversee manufacturing and device quality for commercial devices at its global sites. The role focuses on sustaining activities, changes, audits, CAPAs, and complaint investigations under GMP/GDP and ISO 13485 frameworks.

Based on our Minnesota facility, the position requires hands-on quality leadership across global sites, collaboration with sustaining engineers, and proactive process improvements to ensure compliance and product quality throughout the