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Senior Quality Engineer, Design Assurance

Company: CareFusion
Location: San Diego
Posted on: December 5, 2019

Job Description:

Job Description SummaryAs directed by the Quality Manager, the Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Job Description Primary Responsibilities and Dutie s 1. Consistent application of technical principles, theories, concepts and quality sciences / tools. 2. Proven problem solving skills 3. Makes measurable improvements to BD processes and procedures 4. Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. 5. Is a team member representing Quality on new product development and sustaining engineering projects. 6. Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc. 7. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training) May perform other duties as required Position-Specific Overview: Specific Focus Areas : As defined by hiring manager for current departmental needs to maximize R & D support, individual must exhibit a depth of knowledge, skills or experience in one or more of the following key focus areas: - Reliability: Understand basic Reliability Engineering practices. Includes familiarity with: Reliability Growth Testing (RDT), Reliability Demonstration Testing (RDT), Life Test, HALT, HASS, Idealized Growth Curve, etc. - Software: Understand the software development (SW) and testing life cycle as defined by ISO 62304. Experience supporting SW-related R & D design change efforts through development and/or testing. Understanding of SW issues tracking, automation, issues tracking, risk assessment and bug containment. - Compliance: Ability to support R & D efforts specifically aimed at compliance with domestic or international (e.g. MDR, IEC 60601, 3rd Edition, ISO 13485) requirements. Experience supporting or navigating such projects. Interacting with governing bodies and test houses. - Injection Molding: Experience with mold tooling and molding processes at minimum. Scientific Molding, polymer science, injection molding, blow molding, liquid injection molding (LIM), metal injection molding (MIM), extrusion, process optimization. Scope of Responsibility: - Contributes to the completion of specific programs and projects. - Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers - Prepares/Revises policies/procedures. - May be expected to make presentations Sphere of Influence: The degree to which a position influences and guides business activities, decisions and processes within a function or unit, as well as across organization boundaries and examples. Specific scope of responsibilities is to be based on the specific role - Works under general direction. - Independently determines and develops approach to solutions. - May provide guidance and work direction to lower level project developers - Designs and performs development working independently within defined parameters with minimal supervision required KSA Requirements (Knowledge, Skills, and Abilities) - Knowledge - Applied knowledge of applicable regulatory, Corporate and/or Unit requirements. - Education/Degree - Bachelors Degree in Engineering required - Experience (indicate the number of years) ) - A minimum of 5 years relevant experience or a combination of equivalent education and relevant experience. Primary Work LocationUSA CA - San Diego TC Bldg C & D Additional Locations Work Shift

Keywords: CareFusion, San Diego , Senior Quality Engineer, Design Assurance, Engineering , San Diego, California

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