Sr. Technical Writer

6 days ago

Campbell, United States LanceSoft Full time

Company Overview: Specific Diagnostics, is a medical device company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST directly from positive blood cultures. Our mission is to provide innovative and reliable medical devices that improve patient outcomes and enhance the life of people around the world. Our team of highly skilled professionals is dedicated to excellence in research, development and manufacturing and we are looking for a Technical Writer jo Join our Research and development department. Job Overview The Sr. technical Writer will be responsible for creating and managing documentation for the Research and Development department. This position requires a thorough understanding of medical device development processes, documentation requirements and regulatory compliance. The technical Writer will work closely with cross-functional teams, including Engineers, Scientists, Regulatory Affairs and Quality Assurance, to ensure accurate and timely documentation is produced. Primary Duties: Develop and maintain technical documentation that meets organizational standards, including but not limited to, standard operating procedures, procedures, design specifications, study protocols, study reports, verification and validation reports, instruction for use and user manuals. Coordinates change requests within change management process for R&D (change in specifications, labeling, SOP) Reviews and audits other technical publications deliverables and consistently delivers quality documentation. As regulations change and quality systems are merged/aligned, execute the creation/refinement of documentation. Creates end-user regulatory complaint product labeling. Contributes to new product development and design change activities in the areas of labeling design/release, technical writing, development of artwork/images and development. Collaborates with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent. Manages the review and approval process for all technical documentation to ensure compliance with regulatory requirements. Ensures documentation is up-to date, accurate and accessible to all stakeholders. Assists in development and implementation of documentation standards, policies and procedures. Provides weekly summary of activities, creates project plans for tasks assigned, prioritizes, and effectively communicate updates to customers. Follows Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training. Knowledge, Experience, Skills: Bachelor's degree or Master's in engineering, Science, or a related field. 3-5 years of experience in technical writing for medical device development of complex systems including hardware, software, and reagents. Experience working in a regulated industry such as FDA or ISO. Experience with electronic document management software (Livelink or similar) for tracking and processing document change requests. Experience with Quality Management System. Experience with Product Development and Design Control Processes. Proficient in documentation tools such as Office, Adobe Acrobat and content management systems. Excellent written and verbal communication skills with the ability to effectively communicate technical information to a variety of audiences. Strong attention to detail and accuracy. Ability to work collaboratively in a cross-functional team environment. Ability to prioritize and manage multiple projects simultaneously. Employee Benefits: At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits: Four options of medical Insurance Dental and Vision Insurance 401k Contributions Critical Illness Insurance Voluntary Permanent Life Insurance Accident Insurance Other Employee Perks About LanceSoft LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch. EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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