BD (Becton, Dickinson and Company) Director, Supplier Quality in San Diego, California
Job Description Summary
The Director, Supplier Quality is responsible for building and maintaining the total quality policies, procedures, standards, and controls throughout the supply base that comply with domestic and international regulatory requirements. The scope of this role includes all quality assurance, control and monitoring, and engineering activities to select, maintain, and improve incoming quality levels.
Lead Supplier Quality team to support and, more importantly, enhance the quality of BD products in the MMS Business Unit.
Ensure adequate definition and staffing of the Supplier Quality Engineering and Supplier Assurance teams to support the missions of Operations and Operations Quality.
Ensure that all critical supplier processes are under a state of control and predicatability through the application of capability analysis, risk management, and control and monitoring systems.
Establish and improve a deliberate and disciplined Critical-To-Quality (CTQ) program to establish focus and capability on critical supplier processes and their characteristics to support the critical features of MMS products
Ensure supplier process qualification and validation processes are adequately defined and well executed.
Partner with peers in Operations, Engineering, Supply Chain, Design and Development Quality to manage the priorities and strategies for the Supplier Quality Team.
Manage supplier nonconformances through the SCAR systems, and maintaining effective inspection systems, equipment, and personnel to meet the demands for throughput and quarantine as established by Operations cadence.
Define and execute an effective supplier-based in-process inspection process and ensuring that inspections use qualified methods, and are focused on characteristics requiring inspection. Additionally, ensure that inspection reliance is reduced where possible through process capability enhancement.
Ensure the activities of Suppliers are in compliance with both domestic and international requirements as prescribed thorugh an effective Supplier Assurance auditing process.
Lead Supplier Quality organizations with focus on continuous improvement, risk reduction, efficiency and cost of quality improvements.
Lead efforts to identify supplier quality problems and ensure a structured problem solving method is used, quarantine and control activities are effectively executed, and any required escalations to CAPA or field action.
Ensure timely resolution of corrections and corrective actions.
Ensure that the supplier quality organization meets established quality goals and objectives.
Develop and maintain a customer-focused outreach program to actively seek internal customer input in supplier-caused issues
Provide guidance and influence for sustaining engineering efforts related to improvement in customer satisfaction and product quality.
Interface directly with Design and Development Quality to facilitate effective Design Transfer into a state of control and monitoring.
Establish and manage the yearly budget and control spending.
Develop and execute resource plans to ensure appropriate staffing levels to accomplish assigned organizational objectives.
Ensure the Supplier Quality team maintains training status in compliance with business unit goals
Manage quality interfaces with external business partners and suppliers.
Education and Experience Required:
10-15 years’ experience in a significant Quality and Compliance management role in the medical device industry.
Minimum of a Bachelor’s degree (technical/science related field preferred).
Current or past certification to ASQ’s quality engineering, management or auditing certification is desired
Six-Sigma leadership or experience desired
Demonstrated ability to lead and develop a Supplier Quality organization.
Possesses an aptitude for problem solving and has direct experience in Quality Assurance, process capability, and engineering in a manufacturing environment.
Experience in Quality requirements for domestic and international markets.
Demonstrated ability to manage FDA and other regulatory audits and inspections.
Experienced and training in ISO guidelines as appropriate.
Must have excellent oral and written communication skills and have the ability to relate well to all organization personnel.
Must represent the company in a professional manner to outside entities.
Must possess the ability to motivate and gain a uniform understanding about compliance from all levels of personnel within the organization.
Education and Experience Preferred:
- An advanced degree is desired.
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 Location
USA CA - San Diego TC Bldg C&D
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.