Responsible of guaranteeing the correct process of the documentation as part of the creation or modifications structures, blueprints, products and documents following the procedures and applying norms.
Key Responsibilities:
• Validate that changes submitted are according to the established requirements.
• Execute changes, document posting, the structure creations and or documents in the pertinent systems and supporting the correct implementation of them.
• Follow up changes in all the stages to assure they are completed in time.
• Take care of the metrics fulfillment in the area and its correct implementation.
• Other incidental duties
Education and Experience:
H.S. Diploma or equivalent No previous experience Required
Bachelor's Degree Preferred
Additional Skills:
• Good interpersonal skills, written and verbal communication
• Good knowledge with a variety of software packages, including MS Word, PowerPoint, Excel, and Outlook
• Moderate knowledge and understanding of policies, procedures, and requirements
• Basic problem-solving and organizational skills
• High attention to detail in every role aspect
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Ability to understand the blueprint of engineering the material list and operational procedures.
• Ability to read and comprehend the required English Written and spoken Basic English Preferred.
• Ability to comply with the standards, regulations, procedures and quality manuals applicable to Edwards Lifesciences.
• Ability to receive and provide feedback in a professional, direct, and tactful manner
• 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
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.