Title: Principal Quality Engineer (Design Assurance)
Location: California-Palm Springs-Palm Springs - Bird Center Dr
Job Title: Principal Quality Engineer (Design Assurance)
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* Work with cross-functional teams to assure their product development, verification and validation activities and the resulting work products are in compliance with applicable regulations and standards.
* Proactively develops and maintains broad knowledge of product development best practices.
* Establishes and/or improves product/process quality individually and through team based problem solving efforts.
* Lead and ensure completion of Risk Management activities.
* Establish quality standards for products, processes and procedures.
* Support multiple projects at varying life cycle stages.
* Participate in Product Life Cycle Phase Reviews.
* Enforce product release and configuration management procedures.
* Support all on site audits
Design Assurance, Quality Assurance,
Job Family Summary
Design Assurance - Quality Engineering is responsible for quality evaluation and control of the product development projects. Works cross-functionally in the product design and or maintenance of product design changes. Ensure that appropriate development activities are in place, consistent with business objectives and regulatory requirements.
What is expected of you for success in your role
* Applies intermediate understanding of regulatory requirements for Medical Devices (cGMP, FDA, ISO, etc.) to support work with little or no supervision.
* Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces.
* Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results.
* Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.
* Encourages informed Risk-taking and acts as a catalyst for innovation at CareFusion; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.
* Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity
* May act as mentor to less experienced team members
* Bachelor''s degree in engineering or quality and 3 years of experience as a design or quality engineer
* ASQ (or equivalent) Certified Quality Engineer (CQE) or Software Quality Engineer (CSQE)
* 2-4 years direct experience in a Product Development or R&D Organization
* Excellent communication skills
* Self motivating and able to balance multiple priorities and tight deadlines with minimal supervision