Staff Engineer - Quality Document Systems

Becton Dickinson Medical Devices • Durham, NC

1d • Onsite

About The Position

The Staff Quality Document Systems Management Engineer is a key member of the Quality organization and is responsible for technical oversight and continuous improvement of document and change management processes within the Quality Management System (QMS). The position is accountable for the support of the continued development, improvement, implementation of the Quality Management System as well as maintaining compliance to regulations, standards, and corporate requirements. The role supports broader QMS activities including compliance, audit readiness, and process optimization. This position involves monitoring QMS activities, managing audits, and implementing quality control measures to maintain and enhance our QMS framework. 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

• Bachelor's degree in a relevant degree field (engineering, life sciences, quality, or related).
• 10 years' experience with emphasis on QMS administration, change management, document control, and audit management.
• At least 8 years of medical device or life science industry experiences.
• Proficient communication, organizational, and interpersonal skills with the ability to influence at all levels.
• Collaborative ability to work with diverse cross-functional teams.
• Effective technical writing and excellent analytical, problem-solving, and decision-making abilities.
• Ability to perform multiple tasks simultaneously and prioritize workload with minimum supervision.

Nice To Haves

• Demonstrated experience in managing audits and CAPAs is highly desirable.

Responsibilities

• Spearhead quality management initiatives related to QMS processes, procedures and quality standards.
• Collaborate with diverse teams across departments to elevate our compliance standards
• Take ownership of our Learning Management System (LMS) as the Local Process Coordinator.
• Design engaging, effective training curricula specifically for Pharmacy Automation
• Apply expert document control, change management and system administration principles to both new and existing quality processes
• Serve as the go-to Subject Matter Expert (SME) for electronic documentation systems
• Guide teams through compliance procedures with your exceptional attention to detail
• Plan and manage both internal and external audits with precision and foresight
• Track observations and transform them into actionable insights
• Partner with cross-functional teams to ensure regulatory compliance
• Develop strategic corrective action plans that address the root cause of issues
• Help develop and implement robust quality assurance programs
• Eliminate redundancies and create consistency across all quality practices
• Monitor key performance indicators and translate data into meaningful quality improvements

Benefits

• A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
• It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
• At BD, you’ll discover a culture in which you can learn, grow, and thrive.
• And find satisfaction in doing your part to make the world a better place.

What This Job Offers

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