Senior Risk Management Leader

2 weeks ago

San Diego, California, United States BD (Becton, Dickinson and Company) Full time

Job Overview

Position Summary

We are the creators of possibilities.

BD stands as one of the foremost global medical technology firms, dedicated to enhancing health worldwide. Our mission is significant, requiring the creativity and dedication of our diverse teams—from design and engineering to the production and marketing of our extensive range of MedTech products. Together, we tackle challenges and discover innovative solutions that transform aspirations into reality.

We recognize that the human element within our global workforce is vital for our continuous evolution. Join us to experience an environment that fosters learning, growth, and the pursuit of excellence. Become a creator of possibilities with us.

The selected candidate will ensure that products are designed safely and effectively, adhering to both FDA and BD standards. This role involves leading a team of quality engineers and scientists focused on Risk Management, responsible for developing and maintaining risk management protocols and documentation for BD Dispensing products and services. The incumbent will provide expertise in design quality, risk management, and reliability to colleagues, external regulators, and notified bodies, ensuring compliance with BD quality systems and all relevant regulations.

Key Responsibilities:

  • Oversee quality team members and systems that support design and development activities, particularly in risk management.
  • Establish and continuously enhance systems and procedures related to risk management, reviews, and remediation.
  • Maintain an in-depth understanding of products to assess risk implications and facilitate cross-functional knowledge sharing.
  • Collaborate with leadership and corporate representatives to set and achieve annual performance metrics.
  • Lead Human Factors Evaluation and Reporting initiatives.
  • Direct the assembly of the Safety Assurance Case process and its outputs.
  • Conduct or assist in internal audits and serve as a Subject Matter Expert for external audits and inspections.
  • Ensure consistent adherence to Quality Management System (QMS) requirements.
  • Mentor and develop team members to ensure compliance and escalate quality issues to senior management as needed.
  • Perform additional tasks as assigned.

Qualifications

Education & Experience:

  • Bachelor's degree in Quality Assurance, Mathematics/Statistics, or a related scientific field is required.
  • A minimum of 5 years of experience in quality processes/systems within manufacturing, particularly with cGMP, medical device, and ISO regulations.
  • At least 2 years of experience in leadership and management roles.
  • Proficient in risk management techniques and processes.

Essential Skills:

  • Advanced skills in Risk Management and Risk Analysis.
  • Strong Leadership and Communication abilities.

Proficient Skills:

  • Knowledge of Quality Systems (cGMPs and ISO).
  • Project Management and Problem-Solving capabilities.
  • Experience with Six Sigma methodologies.
  • Team Building expertise.

At BD, we are committed to investing in our associates, focusing on their well-being and development, and providing a competitive package of compensation and benefits. We value your contributions and encourage a culture of accountability and continuous improvement.

To learn more about BD, please visit our website.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer, committed to diversity and inclusion in the workplace.

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