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

Nextern; Maple Grove (MN); Sur place; USD 100 000 - 135 000; Plein temps

Avantages offerts par ce poste

Health Care Plan

Retirement Plan

Paid Time Off

Personal Days

Birthday Holiday

Lifetime Membership Subsidy

Wellness Resources

Life Insurance

Family Leave

Disability Insurance

Taco Thursdays

Résumé du poste

Nextern seeks a senior Quality Assurance Engineer focused on manufacturing quality for commercial devices. You will own sustaining activities, CAPA and nonconformances, ensure compliance with GMP and 21 CFR 820, and support audits across global sites.

You will collaborate with cross-functional teams to drive improvements, maintain DMRs, and lead PLM-related changes to sustain product quality. The role requires a BS in engineering, 5+ years in medical device quality, and experience with ISO

Qualifications

• BS in engineering required.
• 5+ years in medical device manufacturing quality.
• Experience supporting global manufacturing sites.
• Knowledge of 21 CFR 820 and ISO 13485.
• Fluent in electromechanical terminology and components.
• Strong GMP, GDP understanding.

Responsabilités

• Work on-site in US facility, supporting Vietnam and Costa Rica sites up to 20%.
• Receive, open, investigate and trend complaints.
• Identify, own, and execute nonconformance investigations and CAPAs.
• Compile, summarize, and present data internally and to customers.
• Partner with sustaining engineers to implement changes and drive improvements.
• Draft and approve project deliverables and engineering work orders.
• Review and approve changes to parts and documentation.
• Facilitate shipments between sites and customers.
• Coordinate and perform process output testing (verification/validation).
• Maintain Device Master Records (DMR).
• Own manufacturing/DHR reviews for root cause investigations.
• Lead GMP and GDP practices across the organization.
• Identify opportunities to improve Quality System requirements.
• Lead PLM architecture and changes as needed.

Connaissances

Quality systems

CAPA

Root cause analysis

GMP

ISO 13485

PLM

Minitab

Electrical concepts

Documentation

Quality tools

Formation

Bachelor's degree in engineering

Outils

Windchill

Agile

Propel

Description du poste

Nextern seeks a senior Quality Assurance Engineer focused on manufacturing quality for commercial devices. You will own sustaining activities, CAPA and nonconformances, ensure compliance with GMP and 21 CFR 820, and support audits across global sites.

You will collaborate with cross-functional teams to drive improvements, maintain DMRs, and lead PLM-related changes to sustain product quality. The role requires a BS in engineering, 5+ years in medical device quality, and experience with ISO