*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:*Principal Quality Engineer (Design Assurance and Risk Management)
*Job Family Group (Function):*Quality & Regulatory Affairs
*Job Family:*Quality Engineering
*Track/Level:*P3
*CareFusion Business Description*
CareFusion offers advanced cardiopulmonary diagnostic instrument manufacturing, connectivity and support. Meeting diverse needs across respiratory, sports medicine and other markets, our portfolios include spirometry/screening, pulmonary function testing (PFT), metabolic testing products and products for sleep medicine. Learn more: http://www.carefusion.com/medical-products/respiratory/cardio-pulmonary-diagnostics/
*Accountabilities*
The incumbent is responsible for supporting the Design Quality Assurance platform within the Respiratory Diagnostics business (i.e. new product design and development, design transfer, design validation, design review, risk management, DHF review, etc.). The incumbent works closely with RD&E regarding active product quality planning (APQP) that will have significant impact on the business. The incumbent maintains communication with the Regulatory Affairs Manager for the Respiratory Diagnostics Business Segment, for assistance in resolving major quality initiatives/projects and executing design, development, and design transfer initiatives.
The incumbent works closely with RD&E, Manufacturing, Sales, Marketing, and Operations. The incumbent interacts with Regulatory Affairs regarding new regulations and standards as they apply to new product development regulatory submissions, with professional teams on complaint handling/resolution and field actions pre-/post- product launch, Packaging Technology Center on new product packaging projects, and with Business Unit Management regarding product new design and development as well as design transfer issues. The incumbent works in Risk Management Teams during the complete Development Life Cycle Process (DLCP). The incumbent works with various departments and drives CAPA throughout the organization as a CAPA Champion.
The effectiveness of this position can be measured by the health state of Design Quality Assurance (e.g. successful new product design launches) and critical activities/projects, as assigned, that contribute to the success of the business.
The incumbent reports directly to the Design Assurance / Regulatory Affairs Manager for RDx. The incumbent works cross-functionally BU Design Assurance teams on matters related to new product design, design transfer, risk management, process/product design, international product registration, quality improvement projects (QIPs) & plans, and active product quality planning (APQP).
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*The major activities of the incumbent are:*
* Design Assurance: Quality Planning (i.e. new product development, design excellence, and design transfer).
* Design and development planning, design input, design output, design review, design verification, design validation, design changes, and design history file maintenance.
* Design control excellence: Ensure design control program/process is best-in-class.
* Regulatory compliance: Regulatory compliance projects/initiatives, as assigned, in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, CMDR, MDD, J-PAL and relevant guidance documents (FDA, MEDDEV, NB-MED and ghtf Recommendations)
* Design risk management: Assure that appropriate risk management tools (i.e. FMEA's) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards (ISO/EN 14971) and industry practices.
* Supervision and contribution to pre and post market risk assessments.
* International product registration: Preparation of Design documents that meet the specified Regulatory demands of foreign country authorities.
* Supplier audits: Evaluation of new suppliers to support design and development and to drive supplier improvement efforts.
* APQP: Active product quality planning (APQP) through the use of quality control plans and product & process FMEA tools.
* CAPA: Initiating and directing corrective and preventive actions to problems/issues relating to process and/or product quality, such as complaint resolution, customer interface, and regulatory action.
* CAPA Champion: Drives CAPA throughout the organization
* Inspection/Audit coordination: Assisting the BU and Plant Management Representatives in preparation for third party audits (i.e. FDA inspections, notified body audits) and in the effective closure of findings resulting from such audits.
*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 QE policies, principles and best practices
* Demonstrates intermediate knowledge of applicable laws, directives, guidance documents and corresponding harmonized standards
* Demonstrates experience in product risk management and problem solving techniques
* 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 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 discipline required
* Minimum 3 years of experience in the following areas: Quality Engineer in the medical device field, design assurance quality support, medical device manufacturing and design, medical device validation, risk management activities, regulatory compliance, statistics and sampling methods, and CAPA root cause analysis.
* Competencies include: Design control, project management and people skills, excellent verbal and written communication skills, strong multi-task and situational management, personal and group leadership, strong interpersonal skills, excellent computer skills, system management, risk management, and strong results orientation are required for effective performance in this job.
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:** *Principal Quality Engineer (Design Assurance and Risk Management)*
**Location:** *California-Yorba Linda*
**Requisition ID:** *150500Y4*