Senior Quality Engineer - CAPA

Senior Quality Systems Engineer – CAPA & Continuous Improvement

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Senior Quality Systems Engineer – CAPA & Continuous Improvement serves as a subject matter expert (SME) for Quality Systems with primary responsibility for the Corrective and Preventive Action (CAPA) process. This role is responsible for driving CAPA effectiveness, improving quality system performance, and ensuring compliance with applicable regulatory requirements and company standards.

The successful candidate will provide technical guidance, coaching, analytics, and continuous improvement support across the organization while partnering with cross-functional teams to ensure quality issues are effectively investigated, corrective actions are implemented, and quality system processes continue to improve. This position also serves as a key resource for Quality Systems requirements, root cause analysis, compliance initiatives, and quality performance reporting.

• Serve as the Subject Matter Expert (SME) for CAPA processes across the organization.
• Provide guidance and coaching on investigations, root cause analysis methodologies, corrective actions, CAPA documentation, and effectiveness verification activities.
• Monitor CAPA performance and ensure corrective action plans are completed accurately, effectively, and on time.
• Analyze process nonconformances and support the development and implementation of corrective and preventive actions.
• Provide leadership and support for the timely communication and escalation of significant CAPA-related issues to Quality Leadership and Business Unit leaders.
• Collaborate with Post Market Quality to ensure timely completion of nonconformance escalation activities and Situation Analysis reviews.
• Apply Quality Systems principles including CAPA, document control, and related quality processes to support business objectives.
• Provide work direction, mentoring, and support to CAPA owners and project teams as needed.

• Perform data analysis related to CAPA and Quality Management System (QMS) performance to identify trends, risks, and improvement opportunities.
• Develop, maintain, and present quality metrics, KPIs, dashboards, and reports for management and senior leadership.
• Utilize statistical tools and methodologies, including Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE), to evaluate process effectiveness and support data-driven decision-making.
• Support CAPA effectiveness verification activities through statistical analysis, sampling methodologies, and objective evidence.
• Deliver timely and meaningful reports to senior leadership regarding quality system performance and compliance.

• Champion continuous improvement initiatives that enhance quality system effectiveness, compliance, and operational performance.
• Collaborate with CAPA stakeholders across multiple sites to standardize best practices and drive global process improvements.
• Influence cross-functional teams to adopt consistent methodologies, processes, and quality tools across the organization.
• Implement improvements to quality systems, processes, and documentation to increase efficiency and effectiveness.
• Support innovation and quality excellence through the application of data-driven problem-solving methodologies.

• Support the development, maintenance, and continuous improvement of quality programs to ensure compliance with company policies, regulatory requirements, and industry standards.
• Create, review, revise, and approve Quality System documentation.
• Ensure compliance with approved quality methods, Good Documentation Practices (GDP), and quality system procedures.
• Assist with internal audits, external audits, regulatory…