Staff Quality System Specialist II - Document and Data Management (Hybrid/Office)

Job Description SummaryJob DescriptionWe are the makers of possibleBD 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.POSITION SUMMARY:As directed by the Associate Director Global Process Owner Document and Records Management, the Staff Quality System Specialist II - Document and Data Management is accountable for support of the continued development, improvement and implementation of BD's Quality Systems as well as maintaining compliance with regulations, standards, and company requirements. This position actively participates in quality guidance and helps project & quality network teams for process improvement and continuous improvement activities.Focus of this position are Document and Records Management, Change Control, and related process areas, including Implementation and support of electronic/IT systems and tools to support those processes.RESPONSIBILITIES:Identifies and implements improvements to BD's Document and Records Management, Change Control, and related processes and associated electronic/IT systems and tools.

Supports/mentors BD organizations globally in execution/use of Document and Records Management, Change Control, and related processes and systems/tools.

Participates in execution/use of Document and Records Management, Change Control, and related processes and systems/tools in BD's Central Functions organization.

Supports regulatory inspections and audits.

May perform other duties as required.

KNOWLEDGE AND SKILLS:Application of quality system standards as applicable to Document and Records Management, Change Control, and related process areas

Quality System regulatory requirements (e.g. 21 CFR Part 820, ISO 13485) and application to company requirements for Document and Records Management, Change Control, and related process areas

Implementation and support of electronic systems/tools in support of Document and Records Management, Change Control, and related process areas, e.g. SAP ERP, Siemens Teamcenter & Polarion PLM, MasterControl, TrackWise, OpenText/Documentum

Requirements for implementation of electronic systems in regulated environments, e.g. software validation, 21 CFR Part 11

Partnering with corporate technology / IT organizations in the implementation and support of large-scale, global electronic systems

Process improvement techniques (e.g. Six Sigma)

Strong project planning & management, communication, presentation, facilitation skills to ensure successful implementation of projects in a global environment

EDUCATION AND EXPERIENCE:Typically requires a bachelor’s degree in science, engineering, or other relevant field.

A minimum of 12 years relevant experience in regulated environments, preferably medical device or pharmaceutical industries, or a combination of equivalent education and relevant experience.

Industry recognized certification in a Quality related area (e.g. Six Sigma) preferred.

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/careersBecton, 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.PDNPrimary Work LocationUSA NJ - Franklin LakesAdditional LocationsWork ShiftNA (United States of America)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.