QA Engineer Optimal Manufacturing High Quality

QA Engineer Optimal Manufacturing High Quality Job Description Our manufacturing division's "Process Auditor" and "Quality Governance Specialist" is the QA Engineer (Quality Assurance Systems & Regulatory Compliance Specialist). Building, maintaining, and continuously improving the plant's overall quality management system (QMS) is your principal responsibility. This involves turning corporate compliance goals, customer requirements, and broad regulatory frameworks into reliable, routine operational procedures. As the "Guardian of Quality Governance," you assume direct execution responsibility for managing calibration programs, conducting engineering upgrades pertaining to quality standard protocols, conducting internal plant audits, authoring standard documentation, and leading customer fault investigations. Responsibilities: QMS Architecture & Audit Management: To ensure flawless conformance with global standards, maintain, improve, and audit the plant's QMS. Customer and Regulatory Audit Leadership: Present spotless records to get plant qualifications while acting as the main engineering host for external customer audits and regulatory certification visits. Corrective and Preventive Action Leadership: Take control of the plant-wide CAPA tracker and guide cross-functional teams through Fishbone diagrams, 8D frameworks, and 5 Whys to permanently resolve internal and external quality issues. Documentation and SOP Control: Oversee the engineering change loop for all quality documents, examining and approving control plans, inspection guidelines, and standard operating procedures prior to floor release. Advanced Product Quality Planning: Prior to commercial volume run phases, coordinate the earliest APQP stages for new model releases, ensuring that incoming product lines comply with design specifications. Skills: QMS Frameworks & Standard Mastery: Practical experience overseeing formal documentation control tracks along with a thorough understanding of ISO or IATF architectures. Deep fluency with 8D approaches, Fishbone diagrams, and mistake-proofing (Poka-Yoke) models to get rid of process flaws in structured problem solving and root cause engineering. Industrial Metrology & Calibration Governance: A practical grasp of tool precision criteria, MSA frameworks, and gauge calibration standards. Technical Blueprint & GD&T Reading: Excellent ability to accurately interpret geometric dimensioning and tolerancing callouts in engineering drawings. We invite you to apply and explore this exciting opportunity! Warm Regards, HR - Maria