Nextern
Senior Quality Assurance Engineer
Maple Grove, Minnesota, United States · Senior
Sponsorship not specifiedDetected 76 days ago
Product ManagementExcelGMPMedical DevicesLeadershipMicrosoft Office
About the role
- SUMMARY: This role is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle.
- Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues. · Equipment & Process Oversight: Provide quality oversight for IQ/OQ/PQ qualification activities.
- Review and approve protocols, reports, and change orders.
Responsibilities
- Project core team member accountable for operations deliverables including, but not limited to: · Document Control & Audit Readiness: Author and approve SOPs, work instructions, and forms.
- Support internal audits and maintain inspection readiness across the quality system. · Data & Continuous Improvement: Compile and trend quality metrics to identify systemic issues.
- Present actionable insights to leadership and drive implementation of corrective and preventive actions. · Incoming Inspection & Supplier Quality: Oversee incoming inspection per approved sampling plans.
- Evaluate regulatory impact of equipment changes prior to implementation. · NC & CAPA Leadership: Manage nonconformances and CAPAs from initiation through effectiveness verification.
- Lead root cause analysis using structured methods (5-Why, fishbone).
- Quality Assurance Engineers will also support development activities as they prepare to launch into commercial manufacturing, such as manufacturing readiness, audits, and clinical builds to ensure a smooth transition and continuously accurate and compliant Design History File.
- Support internal audits and maintain inspection readiness across the quality system. ·
- Present actionable insights to leadership and drive implementation of corrective and preventive actions. ·
- Manage nonconformances and CAPAs from initiation through effectiveness verification.
Company info
- All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.
Apply directly at Nextern →Create a free account for alerts like thisView Nextern immigration profile
This listing is sourced directly from Nextern's careers page and normalized into a canonical job model.