Quality Assurance Engineer

About the Role At BD, we are committed to advancing quality, compliance, and continuous improvement across our manufacturing operations. As a Quality Assurance Engineer, you will serve as the Quality Subject Matter Expert (SME)for validation, change control, CAPA, statistical analysis, and structured problem-solving activities. This role plays a critical part in ensuring products, processes, equipment, and quality systems comply with regulatory, customer, and internal quality requirements. You will drive operational excellence through proactive problem-solving, data-driven decision-making, risk management, and continuous improvement initiatives to reduce compliance risks, improve process capability, and minimize customer complaints. Working Hours: Monday to Friday : 7:45 AM – 4:45 PM What You'll Do • Lead site-wide Validation and Change Control programs to ensure compliance with quality system requirements. • Manage validation activities and change control processes across manufacturing operations. • Assess validation impact resulting from process changes, quality investigations, CAPAs, and improvement projects. • Provide guidance, training, and mentorship on validation practices, statistical tools, and quality methodologies. • Facilitate root cause investigations using structured problem-solving techniques and quality tools. • Lead and monitor Corrective and Preventive Action (CAPA) programs to ensure timely implementation and effectiveness. • Conduct data analysis and statistical evaluations to support quality improvements and process capability initiatives. • Drive verification of CAPA effectiveness and long-term sustainability through ongoing performance monitoring. • Support quality investigations, risk assessments, and risk management activities. • Participate in and lead continuous improvement projects across the site. • Monitor and report process capability metrics and quality performance indicators. • Collaborate with cross-functional teams to strengthen quality systems and operational excellence. • Promote environmental, health, and safety compliance in accordance with company policies and ISO 14001 requirements. • Support workplace safety initiatives through active participation in safety programs, hazard prevention, and sustainability activities. Job Requirements • Bachelor's Degree in Engineering, Quality, Science, Manufacturing, or a related discipline. • Minimum experience in Quality Engineering, Quality Assurance, Manufacturing, or a regulated industry environment. • Strong knowledge of validation processes, change control, and quality management systems. • Experience leading and managing CAPA investigations and quality improvement initiatives. • Proficient in root cause analysis methodologies and structured problem-solving tools. What’s In It For You • Competitive full‑time compensation package and benefits • Paid company holidays (public holidays, rest days, etc.) • Opportunities for career development and growth • Convenient company transportation provided