BD (Becton, Dickinson And Company) Sandy , UT 84090
Job Description: SummaryThis position is responsible for leading, establishing, and maintaining the electronic document management system for BD in compliance with corporate and regulatory requirements. This position supervises department resources, leads company initiatives, and establishes policies and procedures. This position also oversees the training program at BD Sandy.
Performs supervisory responsibilities for direct reports including performance reviews, recommending salaries and promotions, interviewing and hiring decisions, and disciplinary actions.
Develops and trains direct reports to meet current and future business needs.
Supervises the day-to-day operations of the department and prioritizes projects and tasks to ensure the needs of the business are being met.
Ensures that the highest quality of work is being done while maintaining high efficiency.
Leads, implements and maintains Site Document Control quality system processes and procedures in compliance with applicable standards and regulations.
Controls changes to procedures, policies, Device Master Record, Design History File documents and records through site and corporate policies and procedures.
Serves as Systems Coordinator for corporate product documentation systems.
Serves as a Document Control liaison during inspections and audits including interactions with regulatory inspectors.
May participate as an internal auditor and/or supports internal audits in compiling records necessary to conduct an audit.
Develops, maintains and implements department policies and procedures.
Maintains the external standards library for the site, and issues gap analyses to SMEs.
Oversees the site training program.
Direct supervision of the unit training coordinator, and responsible for hard copy and electronic training records for past and current employees.
Participates in and/or provides training of site employees on site and corporate policies and procedures.
Creates, prioritizes, and tracks internal project implementation schedules.
Represents department and division in ISO and Regulatory agency audits for document and data control issues.
Implement systems to meet changing business needs while maintaining accuracy and traceability of documentation.
Coordinates Site ECRs and trains new ECR requestors.
Reports to Management Review
Manage quality activities to maintain compliance to regulations/procedures and provide support to operational objectives
Assure structure, responsibilities, procedures, processes and resources for the Quality System are available to meet the needs of the site and conform to all applicable regulatory requirements
Effectively supervise and develop others, to build a high performing team
Bachelor's Degree in Business, Engineering, Production Management or a related discipline.
Five (5) years of experience in engineering documentation or equivalency
Three (3) years of experience in a leadership role
Demonstrated communication and human relation skills
Experience in medical device manufacturing or other regulated industry (Preferred)
Two (2) years of supervisor/management experience. (Preferred)
Primary Work LocationUSA UT - Sandy