Quality Engineer II

Overview The 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. Responsibilities Essential Functions: Quality Systems & Compliance Maintain 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 Solving Independently 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 & Calibration Develop, 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 Improvement Apply 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 Control Create, 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 Leadership Provide 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. Qualifications To perform this position successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable Accommodations may be made to enable individuals with disabilities to perform the essential functions. Required and Preferred Skills & Abilities: The qualifications listed below represent the knowledge, skills, and experience typically expected for this role. Candidates who meet most, but not all, of the qualifications are encouraged to apply. Proficient knowledge of optical, mechanical, and dimensional testing and inspection methods and related equipment. Proficient application of statistical concepts and methods to support measurement, process capability, and data-driven decision making. Demonstrated experience using statistical analysis software (e.g., Minitab; Power BI preferred) to analyze trends and variability. Proficient interpretation and application of Geometric Dimensioning and Tolerancing (GD&T) for inspection planning and acceptance criteria. Applied experience using Lean and Six Sigma principles and tools to support continuous improvement initiatives. Working knowledge of ISO9001, AS9100, ISO13485 certified Quality Management Systems; experience supporting audits and maintaining controlled documentation. Demonstrated ability to independently evaluate, troubleshoot, and resolve complex quality and process-related issues. Proficient experience applying Measurement Systems Analysis (MSA) concepts to ensure measurement reliability. Strong written and verbal communication skills, including the ability to communicate technical quality requirements effectively across global teams and stakeholders. Effective collaboration and interpersonal skills, including the ability to work across Quality, Manufacturing, Engineering, and Supply Chain. Strong proficiency with Microsoft Office applications (Excel, Word, PowerPoint); experience with data visualization tools preferred. Experience supporting source inspection and PPAP documentation activities within a manufacturing or supplier environment. Education/Experience: Bachelor’s degree in Engineering, Optics, or related technical discipline or equivalent relevant Quality experience. Typically 5+ years of experience in a manufacturing or industrial quality environment. Lean Six Sigma Green Belt required, in progress, or equivalent demonstrated experience. ASQ Certified Quality Engineer (CQE) preferred or equivalent demonstrated experience. Physical Requirements: Abil