JOB SUMMARY: Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance. Essential Functions, Roles and Responsibilities: 61 Communicate and implement the company’s quality assurance policies and procedures 61 Interpret and implement quality assurance standards of API Q1 and ISO9001:2015 61 Comply with quality management and inspection procedures and directions for recording and reporting quality data 61 Review the implementation and efficiency of quality and inspection systems by planned process audits and workstation audits 61 Audit and monitor testing and inspection activities of materials and products to ensure finished product quality 61 Document internal audits and other quality assurance activities Coordinate to identify training needs and organize training interventions to meet quality management system. 61 Coordinate and support on-site audits conducted by external customers and registrar organizations. 61 Evaluate audit findings and implement appropriate corrective actions 61 Assure ongoing compliance with quality and industry regulatory requirements EDUCATION, TRAINING, EXPERIENCE: 61 Bachelor’s degree preferred, over 5 years quality system implement experience CERTIFICATIONS, LICENSES, REGISTRATIONS: Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate JOB KNOWLEDGE, SKILLS, ABILITIES: 61 Implementation of quality management system, auditing and testing experience 61 Product or industry-specific experience 61 Strong computer skills including Microsoft Office and databases 61 Knowledge of tools, concepts and methodologies of QA 61 Communication skills - verbal and written 61 Data collection, management and analysis 61 Problem analysis and problem solving 61 Teamwork