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Job Title: Principal Quality Engineer (Supplier)
CareFusion Business Description
Our family of ventilation devices including brands like AVEA®, Pulmonetic Systems™ and SensorMedics® diagnostic systems, helps provide safer ventilation and helps to protect patients from ventilator-associated pneumonia. http://www.carefusion.com/healthcare-solutions/respiratory-care/
Responsible for reporting of quality trends and information to management on the performance of sourcing-related quality systems
Interact with external compliance authorities and internal assessment groups to demonstrate regulatory compliance and product safety and efficacy.
Lead and assist with quality systems audits of suppliers (finished goods, components, services, etc.)
Support the development of policies, procedures, quality plans, and methods for Respiratory Consumables to govern sourcing management activities of branded, private-labeled, and distributed products.
Review Quality Systems of proposed new & existing private label & joint label suppliers to verify suppliers’ quality systems comply with applicable FDA and International regulations.
Lead and support supplier improvement initiatives to enhance product quality and supplier regulatory compliance.
Escalate any significant issues.
Provide support to operational excellence initiatives to improve product & process quality and regulatory compliance.
Other tasks & projects, as assigned.
Job Family Summary
Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
What is expected of you for success in your role
Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
Demonstrates intermediate knowledge of FDA/ISO requirements
Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity
May act as mentor to less experienced team members
Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Bachelor's degree in a technical field required. Engineering degree strongly preferred.
Minimum of two (2) years’ experience in the following areas: Quality Assurance/Control, Statistical analysis, FDA QSR's (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC (MDD, CMDR, ISO 13485, J-PAL) requirements.
Medical device or pharma industry experience preferred.
Minimum of one (1) year experience in participating and leading quality systems audits preferred.
Must speak and read fluently both English and Mandarin Chinese
Ability to travel internationally 25%
ASQ certification in Six Sigma Black Belt (SSBB), Quality Engineering, and/or Quality Auditing is strongly preferred.