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Senior Risk Management Leader
2 months ago
At BD, we are committed to shaping the future of healthcare through innovation and excellence. As one of the largest global medical technology firms, our mission is to advance health worldwide.
Our diverse teams, from design to manufacturing, are dedicated to transforming challenges into opportunities that enhance patient care.
Position Summary
The selected candidate will ensure that our products are designed to meet the highest standards of safety and efficacy, adhering to both FDA and BD regulations.
This role involves leading a team of skilled professionals specializing in Risk Management, focusing on the development and maintenance of comprehensive Risk Management processes and documentation for BD Dispensing products and services.
Key Responsibilities:
- Oversee the quality team and systems that support design and development activities, particularly in risk management.
- Continuously enhance systems and procedures related to risk management, reviews, and remediation efforts.
- Maintain an in-depth understanding of products to assess risk implications effectively.
- Facilitate knowledge sharing across various functions to foster collaboration.
- Work closely with leadership and corporate representatives to set and achieve annual performance metrics.
- Lead activities related to Human Factors Evaluation and Reporting.
- Coordinate the Safety Assurance Case process and its outputs.
- Support and conduct internal audits, serving as a Subject Matter Expert for external audits.
- Ensure adherence to Quality Management System (QMS) requirements consistently.
- Guide and develop team members to uphold compliance and escalate quality concerns to senior management when necessary.
- Perform additional tasks as assigned.
Qualifications
Education & Experience:
A Bachelor's degree in Quality Assurance, Mathematics/Statistics, or a related scientific field is required.
Minimum of 5 years of experience in quality processes and systems within manufacturing, specifically with cGMP, medical device, and ISO regulations.
At least 2 years of experience in leadership and management roles.
Proficient in risk management techniques and methodologies.
Essential Skills:
- Advanced expertise in Risk Management and Risk Analysis.
- Strong Leadership and Communication skills.
Preferred Skills:
- Knowledge of Quality Systems (cGMP and ISO).
- Project Management and Problem-Solving abilities.
- Experience with Six Sigma methodologies.
- Team Building skills.
Primary Work Location:
USA CA - San Diego TC Bldg C&D
Salary Range Information:
$155,000 - $256,000.00 USD Annual
