Quality Engineer - 204947

Objective The Quality Engineer will play a pivotal role in enhancing production quality to consistently meet and exceed customer expectations. This position focuses on improving processes and equipment, developing robust quality control systems, and addressing quality system failures through effective root cause analysis. The role also emphasizes driving continuous improvement by implementing Corrective and Preventive Actions (CAPA). The Quality Engineer ensures that all products comply with industry standards, regulatory requirements, and internal quality objectives, while fostering a culture of compliance and continuous improvement throughout the organization. Responsibilities Lead quality-related problem-solving initiatives and root cause analysis in manufacturing to eliminate recurring issues. Investigate technical challenges, oversee testing processes, and establish CAPA strategies to uphold product quality and regulatory compliance. Conduct supplier evaluations, construction surveys, audits, and inspections to verify compliance with quality requirements. Serve as a representative of the quality organization in high-level meetings, addressing critical issues and planning project activities independently. Coordinate cross-functional teams to resolve Out of Specifications (OOS), Deviations, CAPAs, and Change Controls. Identify and analyze quality issues in production and laboratory settings, lead root cause investigations, and evaluate the effectiveness of corrective actions. Collaborate with internal teams to define and track key quality metrics, leveraging data analysis to drive continuous improvement. Develop and update Standard Operating Procedures (SOPs), conduct internal audits, and support training initiatives to promote quality awareness across the organization. Ensure adherence to company policies, procedures, and quality standards, including compliance with Good Manufacturing Practices (cGMP), safety, and environmental regulations. Participate in mandatory safety, GMP, and other company training sessions. Requirements Skills and Competencies Proficient in quality assurance methods, tools, and manufacturing processes. Hands-on experience with quality management software and systems (e.g., CAPA, FMEA, SPC). Strong analytical, critical thinking, and problem-solving abilities. High level of integrity, professionalism, and ethical standards. Excellent communication, organizational, and interpersonal skills, with the ability to work independently and in a fast-paced, cross-functional team environment. Proficient in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to manage multiple tasks and adapt to a dynamic work schedule. Education and Experience Bachelor’s degree in Engineering (Master’s degree preferred). 3-5 years of experience in the cosmetics, medical device, or pharmaceutical industry with a Bachelor’s degree, or 1-2 years with a Master’s degree. ASQ Certified Quality Engineer (CQE) certification is highly desirable. In-depth knowledge of quality systems, including ISO 9001, GMP, FDA regulations, and personal care industry standards.