Quality Systems Lead

Hardware FYI; El Paso, Northern (TX, KY); Hybrid; USD 105,000 - 125,000; Full time

Job summary

BD in El Paso, Texas is seeking a senior Quality Systems lead to direct and improve the QMS across multiple processes. The role includes guiding QA staff, coordinating CAPA activities, and driving compliance with FDA, GMP and ISO standards.

Ideal candidates have 5–8 years in regulated environments and a strong ability to interpret regulatory requirements into practical business solutions. On-site presence is required, with a focus on continual improvement and audit readiness.

Qualifications

• Advanced knowledge of Quality Management Systems and applicable regulations.
• Experience with CAPA, Change Control, Training, Audit, Complaints and Document Control.
• Ability to translate regulatory requirements into practical business solutions.
• 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.
• Lead projects focused on compliance improvements and process optimization.
• Support CAPA activities including investigation, root cause analysis and effectiveness verification.
• Prepare quality system metrics, dashboards, and performance reports.
• Participate in regulatory inspections and customer audits.

Skills

Quality Systems

CAPA

Change Control

Audit

Document Control

Root Cause Analysis

Project Management

Bilingual English/Spanish

Education

Bachelor's Degree

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.

Job Description

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).

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.

Primary Work Location

USA TX - El Paso - Northwestern Dr.