Quality Engineer II - Transcatheter Mitral & Tricuspid Therapies
Employment Type: Full-Time
RELOCATION NOT BUDGETED (Irvine, CA-based position)This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Transcatheter Mitral & Tricuspid Valve repair and replacement. The Quality Engineer II will apply knowledge of technical principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distributionKey Responsibilities:* Investigate complex product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.* Participate in and own escalation tasks and activities, including Project Risk Assessments (PRAs) and Corrective/Preventive action(s) (CAPAs) as determination by investigation.* Identify and report key complaint metrics per device category and collaborate with applicable R&D, clinical development, and manufacturing engineering teams to investigate and resolve device related issues.* Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.* Update and maintain technical content of risk management files.* Support development of moderately complex experiments and tests (including writing and executing protocols) to investigate issues and improve products and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports* Other incidental duties assigned by LeadershipEducation and Minimum Requirements:* Bachelor's degree in Engineering or Scientific field and 2 years relevant industry experience required, OR* Master's Degree or equivalent and internship, senior projects, or thesis in Engineering or Scientific field including relevant industry experience or combined industry/education experience requiredAdditional Talents and General Expectations:* Proven expertise in usage of MS Office Suite including MS Project* Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills* Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering* Strong problem-solving, organizational, analytical and critical thinking skills* Good leadership skills and ability to influence change* Experience with medical devices and knowledge of applicable FDA regulations for medical device industry* Strict attention to detail* Complaints investigation experience and/or hands-on experience with device investigations* Basic understanding of statistical techniques* Ability to interact professionally with all organizational levels and manage competing priorities in a fast-paced environment* Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects* Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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