Validation 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