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Senior Risk Management Leader
2 months ago
We are the architects of innovation.
BD stands as a premier global medical technology firm, dedicated to advancing health worldwide. Our mission is profound, and it requires the creativity and dedication of our diverse teams—from design and engineering to the production and marketing of our extensive range of MedTech products.
We recognize that the human element within our global workforce is pivotal to our continuous evolution. Join us to explore an environment that fosters learning, growth, and the realization of your potential. Become a contributor to our mission.
The selected candidate will ensure that our products are designed to meet both FDA and BD standards effectively.
This role involves leading a team of skilled quality engineers and scientists focused on Risk Management, responsible for developing and maintaining processes and documentation related to Risk Management for BD Dispensing products and services.
You will provide expertise in design quality, risk management, and reliability to colleagues, external regulators, and notified bodies.It is essential to ensure adherence to BD's quality systems, policies, procedures, and all applicable safety regulations.
Key Responsibilities:
- Oversee quality team members and systems that support design and development initiatives, particularly in risk management.
- Continuously refine systems and procedures linked to risk management, reviews, and remediation efforts.
- Maintain an in-depth understanding of products to assess risk implications effectively. Facilitate knowledge sharing across functions.
- 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 act 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 guarantee compliance and escalate quality concerns 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 and 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 expertise in Risk Management.
- Strong capabilities in Risk Analysis.
- Leadership and Communication skills.
Additional Skills:
- Knowledge of Quality Systems (cGMP and ISO).
- Project Management proficiency.
- Problem-Solving abilities.
- Six Sigma methodology.
- Team Building experience.
Primary Work Location:
USA CA - San Diego TC Bldg C&D
Salary Range Information:
$155,000 - $256,000.00 USD Annual
