The Principal Quality Engineering position is responsible for establishing and maintaining an effective quality system in compliance with applicable domestic and international regulations and standards. This position will be accountable for all aspects of quality system processes. This role is integral to ensure product quality, regulatory compliance, and process reliability throughout the product lifecycle. The ideal candidate will have a strong background in design assurance, risk management, and Validation/Verification (IQ/OQ/PQ) activities for product, process, and equipment, ensuring that all deliverables meet customer and regulatory requirements. They will work closely with operations and engineering to ensure quality and manufacturability for both new development and commercial products.