Ensure that Edwards has the key quality information necessary for regulatory compliance.
Key Responsibilities:Evaluate and analyze basic technical information and data related to production quality indicators, identifying trends to establish criteria.Compile data and generate reports for Engineering and other internal customers.Assist with updates to Quality procedures (e.g., inspection improvement initiatives).Assist with developing training materials for quality system related processes.Contribute to Quality, Engineering, and Manufacturing projects.Other duties assigned by Leadership; Support corporate level project management, including representing the department in corporate level initiatives. Execute software validations impacting quality systems. Use JDE to put stop shipment holds on orders. Education and Experience:Bachelor's Degree in Related field, 1 Year experience Required.
Additional Skills:Experience working in a medical device, healthcare, or a related environment preferred.Good computer skills in MS Office Suite.Good written and verbal communication skills and interpersonal relationship skills.Good problem-solving and critical thinking skills.Good knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance.Full knowledge of Good Documentation Practices (GDP).Strict attention to detail.Ability to interact professionally with all organizational levels.Ability to manage competing priorities in a fast-paced environment.Must be able to work in a team environment, including immediate supervisor and other team members in the section or group.Ability to build stable working relationships internally.Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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/control.
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