SUMMARY: This role is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle. 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. 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.

DUTIES AND 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 &am...