Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an impact:
• Ensure compliance with internal procedures, coordinate and perform archiving and control of documentation
• Assist in managing archiving daily activities, including storage and retrieval of records to and from the off-site storage supplier, internal document archival and retrieval process (internal & external) etc.
• Ensure orderly work and proper segregation of documents including storage and identification
• Report, coordinate, and follow up on Annual Document Review of local site SOPs
• Scan, verify and upload documents into Product Data Management System, i.e. APEX, ARAS , Ignite etc. for completed WO, validation reports, TR/TP
• Assist in managing legacy document stored in electronic media as well as ESS and maintain the corresponding inventory list
• Conduct backroom (e.g., documentation preparation room) activities to support external audits and ensure timely response to documentation requests for auditors
• Participate/lead in projects (e.g., documentation remediation) in collaboration with team members; identify opportunities for process improvement
• Support the investigation of non-conformities and CAPAs related to the area including root cause analysis
Other incidental duties assigned by Leadership
What you'll need (Required):
• Bachelor's Degree in related field with 1 year of previous related experience or
• Diploma in related field with 3 years of previous related experience required
What else we look for (Preferred):
• Good computer skills in usage of 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 regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
• Good understanding of medical device documentation development activities
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
• 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
