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Senior Risk Management Leader
2 months ago
Job Overview
Position Summary
We are the innovators of potential.
BD stands as one of the foremost global medical technology firms. Our mission to advance health 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 uncover transformative solutions that turn aspirations into reality.
We value the human element within our global workforce, which enables us to continuously adapt and improve. Become a part of our mission to make the possible a reality.
The selected candidate will ensure that safe and effective products are developed in compliance with FDA and BD standards. This role involves leading a team of specialized quality engineers and scientists focused on Risk Management, responsible for creating and maintaining Risk Management processes 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 adherence to BD's quality systems, policies, and all relevant safety regulations.
Key Responsibilities:
+ Oversee quality team members and systems that support design and development activities, particularly in risk management.
+ Define and enhance systems and procedures related to risk management, risk review, and remediation.
+ Maintain an in-depth understanding of products to assess risk causes and effects, facilitating 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 and support internal audits, serving as a Subject Matter Expert (SME) for external audits and inspections.
+ Ensure consistent execution of 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, adhering to 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 capabilities in:
- Risk Management
- Risk Analysis
- Leadership
- Communication
+ Proficient skills in:
- Quality Systems Knowledge (cGMPs and ISO)
- Project Management
- Problem Solving
- Six Sigma
- Team Building
BD is committed to the well-being and development of our associates, offering a competitive compensation and benefits package. We strive to create a performance-based culture that recognizes and rewards our employees.
Salary Range:
$155,000 - $256,000.00 USD Annually
BD is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on 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.
