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Job Description SummaryThe 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 DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Essential / Key Job Responsibilities:Works within the designated QMS element in accordance with process and procedural requirements.
Participates in meetings and escalations.
Participates in investigations.
Participates in regulatory compliance audits and inspections.
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 completions
Be able to develop and speak to metrics and workload tracking
Be actively engaged in meetings
Accountable for the execution of specific tasks with moderate discretion and with oversight from a supervisor
Introduces or revises Quality system element procedures to maintain or achieve compliance to new or revised regulatory requirements at the direction of Quality management.
Other duties and projects, as assigned.
Required Qualifications: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
Basic understanding of regulations
Ability to organize and analyze data and identify trends to offer solutions.
Experience in electronic document management system, i.e. MasterControl
Ability to prioritize and organize a busy and changing workload
Preferred Qualifications:Basic working knowledge of the regulations.
Prior quality systems, manufacturing, laboratory, or product development experience.
Experience:1 – 3 years relevant experience
Physical Demands:While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.
The employee frequently is required to talk and hear.
The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:General office settingFor 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do 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. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.To learn more about BD visit https://jobs.bd.com/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.PDNPrimary Work LocationUSA AZ - Tempe BPV Building 1Additional LocationsWork ShiftBecton, 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.
Vacancy expired!