Job Description

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