Quality Document Systems Management Specialist
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 Description:
- Participates in investigations.
- Completes applicable job-specific training.
- Effectively manage the end-to-end change lifecycle and identify process improvements where possible.
- Day to day management of change requests.
- Reporting of change to both internal and customer management teams.
- The position will identify and drive continuous improvements to the quality and efficiency of the change management process.
- Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures.
- Documentation origination, editing and revision.
- Creation of change request and associated paperwork utilizing the Electronic Document.
- Management System (EDMS).
- Uses various computer software applications to complete assigned work activities.
- Understanding of compliance requirements and regulations.
- Ability to generate report(s) utilizing the systems.
- Work with teams to determine status of projects/document changes and assist with driving project/document changes to completion.
- Be able to develop and speak to metrics and workload tracking.
- Be actively engaged in meetings.
- Participates in the development of solutions to Quality System problems and/or noncompliance.
- Assists in maintenance of department, site / business unit, and corporate procedures and policies.
- Demonstrates knowledge of operating procedures and expertise in a specific functional area.
- Accountable for the execution of specific tasks with moderate discretion and with oversight from a supervisor.
- Carries out tasks and activities.
- Applies specialized knowledge/skills to perform routine and non-routine work of a group or department.
- Other duties, as assigned.
Essential Job Functions:
- Origination, editing and revision of product documentation.
- Creation of change request and associated paperwork utilizing the Electronic Document Management System (EDMS).
- Assists Project Managers in monitoring the progress of assigned project and makes adjustments as necessary to ensure the successful completion of the project.
- Complete ownership of team documentation for New Product Development (NPD), or product transfers, including creation and launch of change requests (CR).
- Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures.
- Other duties, as assigned.
Basic Qualifications:
- Basic understanding of regulations.
- Advanced language proficiency in reading, writing, understanding, and communicating in English.
- Attention to detail.
- Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
- Intermediate organizational and administrative skills.
- 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 prioritize and organize a busy and changing workload.
- 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.
- Positive and Professional attitude.
- Previous experience in the medical device industry is preferred.
- Ability to read documents in rough draft format and type/format documents consistent with corporate guidelines.
Education and/or Experience:
- Intermediate knowledge of EDMS such as MasterControl, Team Center, Microsoft Word, Excel, and Access.
- 2+ years experience in a document control related position, preferably in an FDA and/or regulated environment.
- High school diploma or GED required.
- Associate's degree in related field preferred.
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/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.
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