BD (Becton, Dickinson and Company) Quality System Specialist in Plainfield, Indiana
Job Description SummaryThe Quality Systems Specialist is accountable for working cross functionally in the application, understanding and compliance of their assigned Quality Systems. The Quality System Specialist reports to the Associate Director, Quality.
Oversee and assure the DC maintains a robust, standardized and effective Quality System which complies with applicable regulatory requirements and Quality Agreements established with business units served.
Responsible for leading local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations.
Ensure the DCs’ processes, organization, procedures, and activities are adequate to effectively meet the needs of the US Supply Chain and conform to all applicable regulatory requirements and regional standards.
Promote a culture of Quality across the local organization that ensures management commitment and understanding of ISO and QSR regulations as they apply to Storage, Distribution and Transportation.
Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance.
Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.
Lead and/or participate in regularly scheduled Quality Leadership calls to ensure timely implementation of agreed upon actions and facilitate cross site exchange of performance and synergistic activities.
Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues.
Maximize the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.
Responsible for managing and maintaining an effective local Quality organization, training, development programs, subject matter expertise, defining and assigning associates’ responsibilities, succession plans, establishing annual IIG’s and evaluating performance.
Serves as a Designated Representative as appropriate to ensure day to day operations meet states’ licensing requirements for medical device and/or wholesale drug distribution regulations as applicable.
Accountable for Quality System as the local Subject Matter Expert (SME), providing guidance and training, facilitating meetings, escalation and ensuring compliance to the following Quality Systems as assigned:
Document and record control, DMS Administrator
Training & Curricula / C2C DLA / GMP & GDP
Data & Analytics
Assist in the execution of CAPAs, Validations, Calibration, and Environmental Monitoring
Designated business unit Quality representative for facilitation of remediation/rework activities with DC personnel. Provides on-site training on behalf of the business units on rework protocols when required.
Partner with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.
Conduct and participate in audits as required in compliance with regulatory requirements, e.g. ISO 13485, 21 CFR 820.
Other duties as assigned.
Experience in Supply Chain and/or Distribution Center Operations preferred
Minimum of 3 years knowledge and experience in a regulated environment; experience in medical devices and/or pharmaceutical regulated industry preferred.
Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820 preferred
Computer skills (Excel, Word, Power Point, etc.)
Process oriented, Continuous Improvement Experience
Strong people leadership including developing, coaching, listening, collaborating, and delegating
Excellent organizational, analytical and process efficiency skills
Excellent interpersonal and communications
Project leadership skills
Initiative and drive for results
BS Degree in Quality Engineering preferred, or related discipline or equivalent work experience
- ISO 13485 and 21 CFR 820 Lead Auditor certified preferred
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.
Primary Work LocationUSA IN - Plainfield
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.