Quality Engineer (QMS)

Becton Dickinson Medical Devices • San Diego, CA

12h • Onsite

About The Position

This role supports the execution of post-market quality processes by managing CAPA documentation, risk file alignment, and recall scoping activities. The position ensures accurate analysis of quality signals, facilitates CAPA investigations, and maintains compliance with regulatory requirements. It contributes to field action planning, prepares materials for internal and regulatory reviews, and provides data analytics to identify trends and support decision-making. Additionally, the role coordinates timely implementation of validated field action solutions and maintains audit ready documentation to uphold product safety and quality standards. We are the makers of possible 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

• B.S. Science, Engineering or other Technical Degree
• Minimum 3 years in medical device quality or regulatory support.
• Familiarity with CAPA, risk management, and FDA documentation.
• Strong writing and organizational skills.
• Detail-oriented and comfortable working in a fast-paced environment.
• Knowledge of ISO 14971, ISO 13485, ISO 9001, 21 CFR Part 820

Nice To Haves

• Demonstrates exceptional problem-solving skills by analyzing complex dynamics, understanding stakeholder perspectives, and driving timely development and execution of robust field action solutions.

Responsibilities

• Ensure that all CAPAs, Safety Alerts (SAs), Risk Assessments (RAs), Health Risk Assessments (HRAs), and Health Hazard Evaluations (HHEs) are aligned with the applicable risk files and determinations.
• Facilitate updates to risk documentation as needed to reflect current understanding and mitigations.
• Gather and organize data to identify affected units and customers.
• Assist in defining the scope of recalls and field actions, ensuring accuracy and completeness of impact analysis.
• Contribute to the development of presentations and documentation for internal Field Action Committee reviews and external regulatory communications.
• Ensure materials are clear, data-driven, and aligned with quality and regulatory standards.
• Drive timely development and implementation of field action solutions by analyzing complex issues, coordinating with collaborators, and ensuring solutions are robust, validated, and aligned with regulatory requirements.
• Ensure quality documentation is properly maintained and audit ready.
• Support audit preparation, execution, and response activities for both internal and external inspections.
• Analyze quality data to support investigations, identify trends, and generate reports.
• Use tools such as Excel, Power BI, or similar platforms to visualize performance and support decision-making.
• Track and manage the execution of field action solutions.
• Ensure that resolutions are robust, approved, validated, and released on time to customers.
• Coordinate with multi-functional teams to meet deadlines and regulatory commitments.
• Analyze Quality Data Trends (15% of Time) and prepare documentation for the facilitation weekly and daily management meetings with collaborators to review metrics and drive accountability.
• Maintain continuous tracking and reporting of performance indicators.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees