Quality Systems Lead

Becton Dickinson; El Paso (TX); On-site; USD 120,000 - 150,000; Full time

Job summary

Becton Dickinson in El Paso, TX, is seeking a senior Quality Systems professional to lead assigned QA processes and guide QA personnel. The role focuses on CAPA, audits, regulatory compliance, and process optimization, with operations anchored in a regulated healthcare environment.

The candidate should have a strong background in QMS, CAPA, Change Control, and regulatory affairs, and be capable of driving improvements across the Quality footprint while collaborating across functions.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Business Administration, or related discipline.
• Minimum 5-8 years of experience in Quality Systems, Quality Assurance, Quality Compliance, or regulated industry environments (preferred).
• Experience in multiple Quality System processes preferred.
• Experience supporting regulatory inspections and audits.

Responsibilities

• Serve as the technical lead for assigned Quality System processes.
• Provide day-to-day guidance to Quality Systems personnel.
• Support workload planning, prioritization, and resource coordination.
• Act as the escalation point for complex quality and compliance issues.
• Drive consistent application and interpretation of quality procedures and regulatory requirements.
• Support Quality Management System initiatives and KPAs.
• Lead projects focused on compliance improvements and process optimization.
• Provide oversight for one or more Quality System processes as needed.
• Facilitate escalation of systemic product or process issues affecting the Quality System.
• Support CAPA activities including initiation, investigation, root cause analysis, action development, implementation, and effectiveness verification.
• Support audit planning, execution, reporting, and follow-up activities.
• Facilitate corrective actions resulting from audits and inspections.
• Support management review activities and quality governance forums.
• Prepare quality system metrics, dashboards, and performance reports.
• Ensure compliance with applicable regulations, standards, and procedures.
• Participate in regulatory inspections and customer audits.
• Support responses to audit observations and commitments.
• Support development and analysis of Quality System performance metrics.
• Monitor process effectiveness and identify opportunities for improvement.
• Conduct trend analysis to identify emerging compliance risks.
• Use data to drive risk-based decision-making and continuous improvement.

Skills

QMS knowledge

CAPA

Change Control

Audit & inspections

Root cause analysis

Communication

Project management

Bilingual English/Spanish

Education

Bachelor's Degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Business Administration

Job description

We are the people who give possibilities purpose 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 MedTech products per year - to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities

• Serve as the technical lead for specifically assigned Quality System processes.
• Provide day-to-day guidance to Quality Systems personnel.
• Support workload planning, prioritization, and resource coordination.
• Act as the functional escalation point for complex quality and compliance issues as needed.
• Drive consistent application and interpretation of quality procedures and regulatory requirements.
• Support departmental objectives and Quality Management System (QMS) initiatives.
• Lead projects focused on compliance improvements, process optimization, and business effectiveness.
• Provide oversight and guidance for one or more of the Quality System processes as business needs deem necessary.
• Facilitate escalation of systemic product or process issues impacting the Quality System.
• Support CAPA activities including initiation, investigation, root cause analysis, action development, implementation, and effectiveness verification.
• Support audit planning, execution, reporting, and follow-up activities.
• Facilitate corrective actions resulting from audits and inspections.
• Support management review activities and quality governance forums.
• Prepare quality system metrics, dashboards, and performance reports.
• Ensure compliance with applicable regulations, standards, and company procedures.
• Participate in regulatory inspections and customer audits.
• Support responses to audit observations and compliance commitments.
• Support in the development and analysis of Quality System performance metrics.
• Support in the monitoring process effectiveness and identify opportunities for improvement.
• Conduct trend analysis to identify emerging compliance risks.
• Utilize data to drive risk-based decision-making and continuous improvement initiatives.

Education and Experience

• Bachelor's Degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Business Administration, or a related discipline (preferred).
• Minimum 5-8 years of experience in Quality Systems, Quality Assurance, Quality Compliance, or regulated industry environments (preferred).
• Experience in multiple Quality System processes preferred.
• Experience supporting regulatory inspections and audits.

Knowledge and Skills

• Advanced knowledge of Quality Management Systems and applicable regulations.
• Strong understanding of CAPA, Change Control, Training, Audit, Complaints, and Document Control processes.
• Ability to interpret regulatory requirements and translate them into practical business solutions.
• Excellent problem-solving and root-cause analysis capabilities.
• Communication and presentation skills.
• Ability to influence without direct authority.
• Project management and organizational skills.
• Support organizational readiness for audits, inspections, and business growth.
• Bilingual - English, SpanishExperience in FDA, GMPs and ISO requirements (preferred).

Primary Work Location USA TX - El Paso - Northwestern Dr.

Additional Locations Work Shift

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.