Quality Document Systems Management Specialist I

Becton Dickinson; Tempe (AZ); On-site; USD 65,000 - 90,000; Full time

Job summary

Becton Dickinson is seeking a Quality Document Management Change Coordinator II to serve as SME for document control and change management, guiding internal and external stakeholders. You will lead projects, improve procedures, and ensure compliance with FDA/GMP standards.

The role emphasizes cross-functional collaboration, data-driven workload analysis, and end-to-end lifecycle management of change requests within EDMS systems such as MasterControl or PEGA.

Qualifications

• Associate’s or bachelor’s degree in a related area or comparable years of experience.
• 1 year of experience in a documentation-related position, preferably in an FDA/GMP-regulated environment.
• 2–4 years relevant experience in quality/document control.

Responsibilities

• Serves as SME for document control and change management processes.
• Leads and executes assigned team projects with minimal supervision.
• Develops and maintains department procedures, policies, and processes.
• Troubleshoots and analyzes quality system issues and nonconformances.
• Drives continuous improvement of change management processes.

Skills

Document control

Change management

English proficiency

Data analysis

Regulatory knowledge

Cross-functional teamwork

Attention to detail

Problem solving

Education

Associate/Bachelor degree

Tools

MasterControl

PEGA

EDMS

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 Responsibilities

• Serves as a subject matter expert (SME) for document control and change management processes, providing guidance, feedback, training, and support to internal and external stakeholders.
• Leads and executes assigned team projects and related processes with minimal supervisory oversight.
• Assists in the development, maintenance, and improvement of department procedures, policies, and operational processes.
• Participates in troubleshooting, root cause analysis, and the development of solutions related to Quality System issues, nonconformances, and process improvement opportunities.
• Provides objective feedback and recommendations to drive continuous improvement in the quality, efficiency, and effectiveness of the change management process.
• Facilitates, participates in, and contributes to meetings related to document control, change management, and departmental initiatives.
• Develops, tracks, analyzes, and presents workload and performance metrics.
• Maintains a compliance-focused mindset and ensures activities align with applicable regulations, standards, and quality system requirements.
• Performs all activities associated with change request (CR) processing, including:
  • Day-to-day management of change requests.
  • Creation of change requests and associated documentation within the Electronic Document Management System (EDMS).
  • Review of change request documentation for accuracy, completeness, and compliance.
  • Creation, revision, and maintenance of controlled documents.
  • Management of the end-to-end change request lifecycle.
  • Reporting the status of in-process change requests to supervisors, project teams, and management.
  • Utilizing approved software applications and systems to complete assigned activities.
  • Collaborating with project teams, document owners, and stakeholders to drive project and document changes to completion.
  • Participates in regulatory audits, inspections, investigations, and other quality system activities as required.
  • Performs other duties as assigned.

Education and Experience

Associate’s degree / bachelor’s degree in a related area or comparable years of experience.

At minimum, 1 year of experience in a documentation-related position, preferably in an FDA and/or GMP-regulated environment.

2 – 4 years relevant experience.

Knowledge and Skills

• Required Qualifications: Ability to perform the duties of a JD-B2-14242 - Quality Document Sys Mgmt. Change Coordinator II.
• Advanced language proficiency in reading, writing, understanding, and communicating in English.
• Attention to detail.
• Intermediate to advanced computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
• Intermediate to advanced organizational and administrative skills including the ability to prioritize, organize, and process a busy and changing workload.
• Intermediate working knowledge of quality management system documentation and records (work instructions, technical documentation, etc.).
• Intermediate understanding of regulations and standards.
• Ability to collect, organize, and analyze data and identify trends to offer solutions.
• Experience in electronic document management systems, e.g. MasterControl, PEGA, etc.
• Ability to work in both a cross-functional team environment and independently with little supervision.
• Ability to work collaboratively with a variety of people at all levels within the organization to ensure effective communication and success of key initiatives.
• Ability to resolve problems by clarifying issues; researching and exploring answers and alternative solutions; implements solutions; escalates unresolved problems.
• Ability to be flexible in work schedule, including a willingness to work overtime as needed.
• Positive and professional attitude.
• Ability to grasp technical terms, processes, and methods.
• Ability to handle a variety of tasks concurrently.

Preferred Qualifications

• Intermediate knowledge in MasterControl or PEGA.
• Prior quality, manufacturing, laboratory, or product development experience.

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 AZ - Tempe Headquarters Additional Locations Work Shift PR 800am-500pm M-F (United States of America)

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on.

We do this because we are committed to advancing the world of health™.

But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond.

We make this happen, together. We are the makers of possible.

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.