Job ID R-303193
Job Description Summary
Senior Manager, Supplier Quality, is responsible for all aspects of Supplier Quality Management for the Device Cluster, comprised of the Medication Delivery Solutions (MDS), Pre-analytical Systems (PAS) and Diabetes Care (DC) Businesses.
Senior Manager, Supplier Quality is responsible for development of the Device Cluster Supplier Quality Management Strategy, and its procedures. This individual provides guidance and support to the Manufacturing sites, Design Centers and Business Units in implementing these procedures, ensuring that each site qualifies and manages its external and internal suppliers, conducts supplier qualification audits/assessments, product quality assessments, ongoing supplier evaluation/audits/assessments, and maintains the Approved Supplier List. This individual provides training to the supplier auditors and site Quality management, as well as leads supplier audits.
This individual supports the identification and qualification of new suppliers during the product design and development process. This individual collaborates with Procurement to resolve supplier quality issues as well as significant risk identified during the routine ongoing management of supplier audits/assessments/evaluations. This individual provides input in the development of the BD Annual Supplier Audit/Assessment plan, and ensures that the supplier audits / assessments assigned to the Device Cluster are executed as per the plan.
This individual represents the Device Cluster in the BD Supplier Management Network which establishes and maintains BD Supplier Quality Management processes.
The Senior Manager, Supplier Quality,reports to Director, Global Quality Processes.
- Leads the development of the Device Cluster Supplier Quality Management Strategy, and its procedures. This includes both internal and external BD suppliers.
- Accountable for the Supplier Quality Management Program lifecycle: Supplier Qualification, External Audits, Quality Agreements, Supplier Notification of Changes, Supplier Corrective Actions and Supplier Monitoring
- Provides guidance and support to the Manufacturing sites, Design Centers and Business Units in implementing the Device Cluster Supplier Management procedures.
- Provides guidance and expertise to cross functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and compliance.
- Ensures that each site qualifies and manages its external and internal suppliers, conducts supplier qualificationaudits/assessments, product quality assessments, ongoing supplier evaluation/audits/assessments, and maintains Approved Supplier List.
- Ensures lead auditors, co-auditors or SME's who support the Supplier Quality Management program receive periodic (e.g. annual) training on current regulatory intelligence trends as identified by the program.
- Audit suppliers and their processes to assure compliance to quality practices and to identify potential risk to product/services supplied to BD. Assure inspection and test is effective and efficient in mitigating quality risk and assuring reliable delivery performance.
- Collaborates with Procurement to resolve supplier quality issues as well as significant risk identified during the routine ongoing management of supplier audits/assessments/evaluations. Promptly escalates and reports all critical audit findings in accordance with BD supplier management policies and procedures.
- Developing systems with the sites to monitor supplier quality to identify and drive Continuous Improvement opportunities and to reduce or eliminate quality problems with incoming product/raw material/components and finished medical devices and IVD’s. Prepares and presents supplier performance metric at Management Reviews.
- Work closely with the complaint management Unit and quality engineering associates monitoring finished device contract manufacturers for complaints and ensuring that corrective and preventive action is performed.
- Provides support to the new product development teams in qualifying new suppliers and define process parameters/criteria to ensure supplier process capability is effective to meet product and process requirements
- Provides support to sustaining engineering teams in managing change notifications from suppliers
- Represents the Device Cluster in the BD Supplier Management Network which establishes and maintains BD Supplier Quality Management processes.
- Provides input in the development of the BD Annual Supplier Audit/Assessment plan, ensures suppliers of the device cluster sites are included, and ensures that the supplier audits/assessments assigned to the Device Cluster are executed as per the plan.
- Must be able to travel to suppliers and BD sites to provide on-site support as needed (approximately 20-30% travel)
Typically requires a minimum of a Bachelor's degree in science, engineering or other relevant discipline with a minimum of 6 years of experience in people or project management role within Quality (with focus on Supplier Management) in a Medical device / In Vitro Diagnostic manufacturing firm.
Other skills include:
- Excellent leadership, communication, organization and project management skills.
- The ability to effectively lead teams and influence.
- The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.
- Effective meeting and presentation skills.
- Ability to perform multiple tasks and prioritize work load.
- Effectively manage conflict.
- Strong knowledge of supplier management practices.
- ISO 13485 Certified Lead Auditor or equivalent experience.
- Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, 21 CFR §820, ISO 13485, MDD (EU MDR), Canadian MDR, TG(MD)R, PMDA, ANVISA, etc.
- The ability to make timely critical decisions regarding product quality and/or quality system compliance.
- The ability to assess and articulate risk when evaluating a situation
- The ability to perform thorough investigations, identify root cause(s) of an issue, and propose appropriate corrective action(s).