Edwards Lifesciences Senior Specialist, Technical Writing in Irvine, California
Professional - Develop and create accurate Good Manufacturing Practices (GMP) technical documents.
SME - Manage unified content strategy for CMS database. Collaborate with stakeholders to develop and monitor use of authoring guidelines and best practices for DITA-based technical writing. Oversee and manage content in CMS platform.
• Provide technical writing expertise to create complex design control documentation packages including process validation documents (e.g, Installation Qualification, Operations Qualification, Process Qualification) Good Manufacturing Practices (GMP) protocols and reports, technical summaries, and test procedures
• Collaborate with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes
• Maintain documentation in a standard format following established guidelines
• Review documents for style, clarity, grammar, and punctuation
• Identify and correct inconsistencies of thought, development, or organization and confer with authors to recommend an appropriate adjustment in documents and procedures
• Recommend improvements to current documentation practices and propose recommended changes
• May lead special projects (e.g implementation of new style of documentation procedures)
• Other duties assigned by Leadership; Provide guidance and training to lower level employees
Bachelor's Degree required
Minimum of three years of technical writing experience
Minimum of three years Healthcare Industry (e.g., Quality Assurance, Regulatory or Operations) preferred
Proven expertise in Microsoft Office Suite including Word, Excel, PowerPoint, and Publisher; Adobe and Photoshop preferred
Excellent editing and proofreading skills
Excellent written and verbal communication skills in English including negotiating and relationship management skills
Excellent problem-solving and critical thinking skills
Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation
Full knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports)
Excellent technical writing skills
Full knowledge of product assembly procedures
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.