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Quality Documentation Specialist (TMTT)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 4, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. This is a unique opportunity to join a fast-paced, transformational Quality team within the Edwards Transcatheter Mitral & Tricuspid Therapies business unit. TMTT is a rapidly developing organization dedicated to innovate and lead treatment for patients with mitral and tricuspid valve disease. This position is an important individual contributor role that will have the opportunity to collaborate with cross-functional teams (R&D, Mfg., Quality, RA, Clinical, etc.) to help manage and implement the configuration of parts and documentation associated with developing and manufacturing product data (DMR) throughout the product lifecycle. This position will assist in coordination & release of product information through the Product Lifecyle Management (PLM) system while maintaining compliance with Regulatory requirements. He/she will help with processing & timely release of change requests per project schedules through collaboration from various levels of the organization. Key Responsibilities: --- Support and process TMTT DMR change requests of documents and parts per project schedules and priorities; support any TMTT Non-DMR change requests for process enhancements. --- Analyze varying complexity of change requests including impact assessment/GDP, required items per change category, and resolving potential issues with collaboration prior to final review. --- Review, implement and manage Part Master, Branch Plant, BOM configuration management in PLM / ERP system. --- Provide Quality Systems knowledge and guidance in creation and revision of documents, timing of release and training activities with content owner. --- Understand relationships and requirements between Product Lifecycle, ERP, LMS, and other change systems; occasionally provide training other team members. --- Lead portions of continuous process improvements focused on Document and Change Control and recommend solutions. --- Support Corporate Quality and Notified Body audit activities for the business unit as needed. Education and Minimum Requirements: Bachelor's Degree and 3 years of relevant experience doing documentation and product configuration in the medical device, pharmaceutical, or biotechnology industry OR Associate's Degree and 5 years of relevant experience doing documentation and product configuration in the medical device, pharmaceutical, or biotechnology industry Preferred Qualifications: --- Some knowledge and experience with ISO 13485 Medical Device Quality Management System --- Experience with project management and project management software tools Additional Talents and General Expectations: --- Good computer skills in usage of MS Office Suite; PLM (e.g., TeamCenter) and ERP (e.g., JDE) --- Excellent written and verbal communication skills and interpersonal relationship skills --- Excellent problem-solving and critical thinking skills --- Solid knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to product change control and documentation --- Solid understanding of medical device documentation development activities and GDP --- 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 --- Adhere to compliance with internal procedures --- Proactive, enthusiastic, and fastidious learner able to adapt to changes and provide sound decision-making --- Must be able to work in a dynamic team environment and represent TMTT business unit on specific projects within a larger organizational setting --- 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/control E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Full time Req-6847 About Us 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Quality Documentation Specialist (TMTT), Other , Irvine, California

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