Job details

Quality Document Sys Mgmt Specialist

Job Description Summary

The position supports the development, implementation, and monitoring of an element or elements of the Quality Management System (QMS), including but not limited to Document Control, Training and Qualification, and Metrics and Data Analysis, and various other elements for the site / Business unit. He / She monitors and maintains applicable procedures for that element of the QMS, and develops, implements or manages applicable instructions, as necessary or directed. The position provides guidance and training to associates for processes associated with their responsible QMS element, facilitates meetings and escalation, and supports departmental and organizational goals and processes. This position is responsible for the creation and processing of all change request packets, creation of controlled documents, tracking of packets and all associated paperwork involved. This requires participation as an active team member in cross functional teams and ownership of project team documentation. Responsibilities also include the origination, editing and revision of technical documentation.

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.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

Effectively manage the end to end change lifecycle and identify process improvements where possible.
Day to day management of change requests
Coordinates and conducts information and training sessions applicable to their designated QMS element for associates, as necessary.
Oversees / Leads monitoring and maintenance of activities associated with and Quality Records generated from their designated QMS element(s) in accordance with process and procedural requirements and reports upward and outward accordingly.
Serves as subject matter expert for their designated QMS element in regulatory compliance audits and inspections, as necessary.
Liaisons with Segment and Corporate on behalf of BDPI, as necessary.
Provides input, feedback and training for other departments.
Reporting of change to both internal and customer management teams
The Document Controls Specialist will drive continuous improvements to the quality and efficiency of the change management process.
Documentation origination, editing and revision
Uses various computer software applications to complete assigned work activities
Understanding of compliance requirements and regulations Ability to generate report(s) using the systems
Facilitates meetings and escalations.
Leads investigations, as necessary.
Other duties, as assigned

Required Qualifications:

Excellent oral and written communication skills in English
Strong attention to detail
Proven experience in working in a cross-functional team environment as well as the ability to function independently
Ability to gather and organize information
Ability to grasp technical terms, processes, and methods
Ability to handle a variety of projects at the same time
Ability to work in a team environment and/or independently with little supervision
Works collaboratively with a variety of people at all levels within the organization to ensure effective communication and success of key initiatives
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 working knowledge of regulations.
Positive and Professional attitude

Preferred Qualifications:

Experience in EDMS (i.e. Master Control, TeamCenter).
Ability to prioritize and organize a busy and changing workload
Ability to troubleshoot system issues without assistance

Education and/or Experience:

Experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)
3+ years’ experience in a documentation related position, preferably in an FDA and/or regulated environment
Associates Degree or equivalent related experience

Location: General office setting, Hybrid schedule based on location

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.