Senior Quality Assurance Engineer

Quality Assurance EngineerThis 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 & 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. 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. 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). Trend data and report findings at management review.• Operations Quality Support:o Act as the quality point of contact for production.o Review batch records and travelers for GMP compliance.o Support line clearances, first-article inspections, and process change reviews.o Draft, collaborate, and approve product and engineering work orders.o Create and maintain up-to-date product Design History Files (DHF).o Advise project teams and lead by example in best-practices for Quality and Regulatory Compliance.o Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed.o Receive, investigate, and document product complaints, interacting with customers as applicable.o Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs.o Drive Product Lifecycle Management (PLM) architecture and changes, as needed.Supervisory Responsibilities:This job has no direct supervisory responsibility.