Technical Writer II

Grifols; San Diego (CA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

PTO

401(k) match

Tuition reimbursement

Job summary

Grifols in California is seeking a Technical Writer II to develop and revise operator manuals, service manuals, and technical bulletins for instrumentation and software. You will gather information from cross-functional teams and ensure documentation adheres to quality standards and regulatory requirements.

The role requires five years of end-user documentation experience, familiarity with medical device regulations, and proficiency in FrameMaker, Illustrator/Visio, and Confluence/Jira for

Qualifications

• Minimum five years of experience writing end-user software or hardware instructions.
• Experience in the medical device industry preferred.
• Experience in federally regulated environments (FDA/UMDR).
• Bachelor's degree in English or Technical Communication or related field.
• Familiar with MS 365, SharePoint, FrameMaker, and Acrobat Pro.

Responsibilities

• Revise and edit legacy product documentation including operator manuals, service manuals, and technical bulletins.
• Manage translation projects with vendors and perform translation reviews for consistency with formatting and layout.
• Effectively manage multiple projects, changes in scope, and shifting priorities to meet deadlines.
• Process documents through the electronic documentation control system (LSQM).
• Maintain version control, change history, and traceability for all deliverables.
• Ensure documentation is accurate, complete, and compliant with regulatory/QSR requirements.
• Create and edit documentation complying with FDA, IVDR, and EU MDR requirements.
• Collaborate with cross-functional peers to resolve questions during development.
• Continuously review the document development process to ensure labeling quality.

Skills

Advanced writing

Editing

Organized

Multitasking

Global collaboration

Change control

Documentation tools

Medical terminology

Education

Bachelor's in English/Technical Communication

Tools

Microsoft 365

SharePoint

FrameMaker

Acrobat Pro

Visio

SnagIt

Confluence

Jira

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

This position will provide technical writing support for instrument and software operator manuals, service manuals, and technical bulletins. As a member of the R&D Instruments group, this position will take in technical information from multiple cross-functional groups to develop instrumentation manuals (operators manuals, service manuals), and technical bulletins.

Primary Responsibilities for Role

• Revise and edit legacy product documentation as required, including but not limited to, operator manuals, service manuals, and technical bulletins.
• Manage translation projects with the translation vendor and perform translation reviews for consistency with formatting and layout.
• Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
• Process documents through the electronic documentation control system (LSQM).
• Manage all aspects of document development and assist in production release, including draft reviews.
• Maintain accurate version control, change history, and traceability for all deliverables.
• Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style.
• Ensure compliance of labeling with all applicable regulatory/QSR requirements.
• Create and edit documentation in compliance with requirements from applicable regulatory bodies (FDA, IVDR, EUDR) and the European Union (EU Medical Device Regulation).
• Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.
• Continually review the document development process to ensure quality in labeling output.

Additional Responsibilities

• Keep track of documentation through the entire development process while adhering to time lines, maintaining revision control, maintaining change lists, and managing reviews
• Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style.

Knowledge, Skills, and Abilities

• Advanced writing/editing skills
• Self-directed and highly organized
• Ability to manage multiple priorities
• Proven ability to work with global stakeholders
• Experienced maintaining accurate change lists, content change control, and file version control throughout the documentation development process.
• Familiar with best practices regarding topic-based authoring, content reuse, conditional text, and variables.
• Medical terminology experience
• Proficient with Microsoft 365 applications, SharePoint, Adobe FrameMaker, and Adobe Acrobat Pro.
• Experienced using Visio and SnagIt Editor or similar applications to create diagrams, illustrations, flow charts, and screenshots.
• Experienced using Confluence, Jira, or similar collaboration and tracking tools.
• Hands-on experience with instrumentation and software
• Familiar with best practices regarding topic-based authoring, content reuse, conditional text, and variables.

Education

• Bachelor's degree, preferably in English or Technical Communication, similar related fields.

Experience

• Minimum five years of experience writing end-user software or hardware instructions.
• Experience in the medical device industry preferred
• Experience working in a federally regulated environment (FDA/UMDR)

The estimated pay scale for Technicial Writer II role based in California, is $90,000 - $110,000per year. A dditionally, the position is eligible to participate in up to 8%of the company bonus pool. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

We offer a wide variety of benefits including, but not limited to:

• Medical
• Dental
• Vision
• life insurance
• PTO
• paid holidays
• up to 5% 401(K) match
• tuition reimbursement

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.