Quality Engineer II

Quality Engineer - Level IIThe Quality Engineer - Level II is an experienced quality professional responsible for independently executing and improving quality assurance processes across manufacturing and inspection operations. This role applies advanced quality tools, statistical methods, and systems thinking to ensure compliance with the Quality Management System and to drive measurable improvements in product quality, process capability, and operational efficiency.The Level II Quality Engineer demonstrates proficiency across core quality competencies and serves as a technical resource to peers, manufacturing, engineering, and cross-functional partners.ResponsibilitiesEssential Functions:Quality Systems & ComplianceMaintain and improve elements of the Quality Management System in accordance with ISO 9001, ISO 14001, AS9100, ISO13485, and other applicable standards.Support internal and external audits by preparing documentation, responding to findings, and implementing corrective actions.Ensure quality requirements are properly flowed down through procedures, control plans, and work instructions.Corrective Action & Problem SolvingIndependently lead Root Cause and Corrective Action (CAR) investigations using structured methodologies.Verify effectiveness of corrective actions and ensure sustainable prevention of recurrence.Analyze trends in CARs, defects, and returns to identify revealing patterns and systemic issues.Inspection, Metrology & CalibrationDevelop, review, and maintain QA control plans and inspection plans for products and processes.Support and manage calibration and measurement systems, including MSA activities.Provide metrology expertise to Quality, Manufacturing, and Engineering teams.Support and perform source inspection activities, including preparation of inspection criteria, review of results, and verification of conformance prior to shipment.Data Analysis & Continuous ImprovementApply statistical analysis tools (e.g., Minitab) to assess process capability, stability, and performance.Facilitate DOE, FMEA, and process capability studies as required.Lead or support continuous improvement initiatives, including 6S and Lean/Six Sigma activities.Analyze PPAP and validation data to assess process capability and readiness for production release.Documentation & Process ControlCreate, revise, and maintain controlled quality documentation including procedures, work instructions, and forms.Support the transfer of inspection and testing methods from Engineering or R&D into Manufacturing.Participate in process documentation development with cross-functional stakeholders.Support and manage PPAP activities, including review and approval of control plans, inspection plans, FAI results, and capability data for new or modified products.Collaboration & Technical LeadershipProvide technical guidance and informal training to Quality Engineers, Technicians, and Inspectors.Act as a quality point of contact for cross-functional teams to resolve complex quality issues.Contribute to cross-functional initiatives involving Manufacturing, Supply Chain, Engineering, and Customer Service.Communicate quality requirements, findings, and corrective actions effectively across global sites, suppliers, and cross-functional teams.