*Life-changers work here*
At CareFusion, we create innovative ways to help our customers improve patient care. We rely on bold and inspired employees who share our commitment to helping solve some of healthcare's most critical challenges.
CareFusion is now part ofBecton Dickinson, a global medical technology company focused on addressing many of the world's most pressing and evolving health needs. With our combined technology and expertise, we will become a global leader helping to transform the quality and cost of care for patients and clinicians worldwide. Join us in our mission to improve the future of healthcare and help all people lead healthy lives.
*Job Title:*Quality Systems Engineer - Internal Audit, CAPA
*Job Family Group (Function):*Quality & Regulatory Affairs
*Job Family:*Regulatory Audit
*CareFusion Business Description*
Our respiratory care and ventilation solutions help manage optimal lung support while transitioning patients across the continuum of care—from the hospital to the home. With our comprehensive portfolio, CareFusion can help enhance patient care and safety while reducing cost. Learn more:http://www.carefusion.com/healthcare-solutions/respiratory-care/
*Accountabilities*
The role of Quality Systems Engineer, Internal Audit is to provide process support for Quality Systems and Internal Audit program in accordance with documented procedures and practices. The incumbent is responsible for the implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in Respiratory Solutions business units. The effectiveness of this position can be measured by the health state of the Quality System, external audit results and internal audit program effectiveness across the Respiratory Solutions business segment.
The major activities of the incumbent are:
* Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other process related documentation.
* Compiles data to monitor effectiveness of Internal Audit Program and Corrective and Preventive actions (CAPA) Program.
* Reports data metrics to proper teams as required by the business
* Identifies and reports process improvements and value-added observations for audited sites that help enhance operational effectiveness.
* Contributes to the design and development of continuous auditing dashboards across Respiratory Solutions sites.
* Assist in completing the annual audit plan.
* Ensure adequate documentation is maintained to substantiate all audit related issues
* Prepare reports of audit and investigative findings, related risks, causes and recommendations for improvement in an efficient, timely concise manner
* Participate on behalf of audit in special projects and investigations, policy and procedure reviews, new product and service development new system application reviews
* Ensure trigger mechanisms are defined and managed appropriately to ensure effective entrance criteria to CAPA system.
* Ensures regulatory compliance and optimization of quality system procedures relating to Internal Audit and CAPA through development, maintenance and adherence to documented processes, development and implementation of employee training, and development and implementation of quality metrics to drive improvement and business results.
* Supports key QA/RA activities as assigned including CAPA investigations, Training, and Internal Auditing.
* Identifies and reports any quality or compliance concerns and take immediate corrective action as required.
* Demonstrates knowledge of applicable laws and regulations to evaluate compliance within a defined scope.
* Responds directly to internal/external customers regarding routine requests in a timely manner.
* Communicates viewpoints effectively and obtains agreement on routine issues.
*Job Family Summary*
Regulatory Audit is responsible for assessing processes and practices for regulatory risk and conformance to quality standards, and working with business and quality leaders to implement improvements.
*What is expected of you for success in your role*
* Demonstrates in-depth experience with applicable laws and regulatory agencies and with knowledge of auditing techniques
* Evaluates compliance status
* Begins to analyze levels of risk
* Reviews corrective action plans
* Recommends compliance enhancements
*Edu**cation*
* This position requires a bachelor degree from an accredited four (4) year university.
*Sk**ills*
* Excellent communication skills: able to clearly communicate complex information in an easy to understand manner; able to deliver message effectively verbally and in writing
* Demonstrated effective interpersonal, teamwork, negotiation & conflict resolution skills
* Strong analytic skills: able to clearly link results to operational performance drivers, and generate alternatives
* Change agent with energy, passion & enthusiasm to drive change
* Strong organizational skills
* Prior experience using word processing, spreadsheet, and presentation software
* Ability to effectively communicate in English
*E**xperience*
* Minimum of 4 years of experience working in regulated environment as medical device, pharmaceutical, etc.
* Minimum of 2 years of experience with CAPA systems
* Lead auditor experience required, ASQ CQA certification or comparable certification preferred
*Sp**e**cialized Knowledge*
* Strong understanding of the medical device and pharmaceutical quality system regulations and industry standards
* Ability to identify root cause of problem, and creatively problem-solve to gain resolution
* Advanced skills in working with or within an IT organization as it applies to Quality Systems IT
* ASQ certification in Quality Engineering (CQE) preferred
CareFusion is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.
*LI-AB1
**Title:** *Quality Systems Engineer / Internal Audit*
**Location:** *California-Yorba Linda*
**Requisition ID:** *150500OY*