Job Description Summary

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.

Job Description

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. 

Job 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

Required Qualifications:

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

Knowledge and Skills:

• 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. 

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?

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.  

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 health. 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.  

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.

Required Skills

Optional Skills

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Primary Work Location

USA NC - Durham - Roche Drive

Additional Locations

Work Shift