Senior Quality Manager

Becton Dickinson Medical Devices•Plainfield, NJ

3d•Onsite

About The Position

This role’s primary responsibilities include assuring the DC maintains a robust, effective Quality Management System that complies with applicable regulations, laws, and BD procedures. The role will provide Quality oversight at BD’s large capacity DC with greater levels of complexity due to the number of business units served, in addition to supervision of services provided such as returns, re-boxing, etc. The Sr. Quality Manager assures the local organization, and resources adequately support BD’s requirements and priorities to create customer value addressing elements critical to business success.

Requirements

B.S . or .B.A. in Engineering, or Science
8-10 years experience leading a quality function
QMS experience in medial device preferred
CFR 210/211/820, ISO 9001/13485 requirements
Good Warehouse and Distribution Practices
ERP/WMS quality functionalities
Analytical thinking and problem solving skills
Multi-functional working matrix
Influencing others

Responsibilities

Responsible for the development, maintenance, and execution of the DC Quality Management System in compliance to ISO 13485, 21 CFR 820 (QSR), BD Corporate Policies and Procedures, Regional Quality Standards, BU Quality Agreements and other applicable regulations.
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.
Responsible for establishing and leading local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations.
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.
Applies metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.
Employs and share standard processes and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and standard process concepts; to introduce pro-active improvement and prevent recurrence of issues.
Partners with the businesses and provide summary input on key packaging and configuration issues to maintain document currency to product and customer requirements.
Effectively evaluates and provides direction to the DC with inventory that has suspected damage and is at risk of being scrapped.
Manage the ERP non-conformance process, collaborate on issues to provide detailed information to source plants, vendors, or carriers to determine root cause.
Monitors for trends, critical issues, and partner with sources of root causes to implement effective corrective actions that reduce non-conformances and risk in future shipments.
Oversees and monitors the scrap process to ensure compliance to procedure, timeline, and regulatory requirements (Haz waste)
Facilitates the critical issue process with businesses for disposition of inventory identified as non-conforming is not meeting established timelines.
Responsible for managing and maintaining effective non-conforming product (Global Hold, Local Hold, Ship in Quarantine, Damages, etc.)
Responsible for managing and maintaining effective, efficient Returns operation that improve value to the region and meet established performance metrics.
Responsible for managing and maintaining effective, Rebox operation that meets applicable regulatory and business unit requirements, improve value to business units served and meet established performance metrics.
Collaborate with Transportation on carrier related issues and driving claims to resolution where escalation is needed. Also assist Supply Chain and partner with BD businesses on carrier related issues where root cause analysis and corrective actions are initiated to improve carrier performance.
Partners with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.
Generates monthly and quarterly metric reports for regional leadership review.
Attend and participate in Regional DC Quality metric calls.
Represent Quality as a member of the local DC leadership team.
Attends weekly and/or monthly site manager/process owner meetings as established.
Conducts audits as required in compliance with regulatory requirements, e.g. ISO 13485, 21 CFR 820.
Travels up to 25% of the time to support Quality Management and audit functions at other DC facilities, and support Customer visits to gain an understanding of Customer issues, determine root cause, establish and drive corrective actions and improve Customer satisfaction.