Quality Process Engineer

Process Engineer – Quality FocusThe Process Engineer – Quality Focus is responsible for developing, validating, controlling, and continuously improving manufacturing processes, with an emphasis on process capability, product quality, and long-term process robustness within a regulated medical device manufacturing environment.This role serves as the technical owner of injection molding and secondary manufacturing processes, ensuring processes are capable, compliant, sustainable, and aligned with internal quality standards, customer requirements, and regulatory expectations. The Process Engineer partners closely with Quality, Production, Tooling, Maintenance, Engineering, and Program Management teams to support daily manufacturing operations, new product introductions, and continuous improvement initiatives.Essential Duties and ResponsibilitiesProcess Ownership & ControlDevelop, establish, optimize, and maintain robust manufacturing processes for plastic injection molding and secondary operations.Serve as the process owner for assigned manufacturing cells and production lines.Define and maintain critical process parameters, validated process windows, and process control strategies to ensure consistent product quality and process stability.Monitor process performance utilizing SPC, capability analysis, and other statistical tools; respond appropriately to trends, variation, and out-of-control conditions.Troubleshoot molding and manufacturing process issues to improve efficiency, reduce variation, and minimize downtime.Support the establishment of standard process settings, setup instructions, and manufacturing best practices.Process Validation & Technical DocumentationLead and execute process validations, including IQ, OQ, and PQ activities, for new and existing products in compliance with applicable medical device regulations and internal procedures.Develop, review, and maintain technical manufacturing documentation, including:Process Flow DiagramsProcess FMEAs (pFMEAs)Control PlansWork Instructions and Setup StandardsValidation Protocols and ReportsEnsure validation activities support long-term process capability and sustained manufacturing performance.Support change control activities related to materials, tooling, equipment, and process changes.