
Website RandstadUSA Randstad USA
Job summary:
A Technical Writer for a medical devices and equipment manufacturing company is needed in the Fremont, CA area. The Lead Analyst, R&D Technical Writing, develops compliant product labeling and technical documentation for new and existing products, leads quality improvement initiatives, and ensures regulatory readiness through expertise in design software, labeling systems, and documentation standards.
location: Fremont, California
job type: Contract
salary: $64.29 – 78.57 per hour
work hours: 8am to 5pm
education: Bachelors
Responsibilities:
- Create regulatory-compliant, end-user product labeling for both new and existing products.
- Design, develop, and release label artwork and product images.
- Lead or collaborate on continuous improvement and special projects affecting business impact.
- Engage and coordinate with cross-functional teams to resolve labeling and process-related challenges.
- Provide weekly status updates, project plans, and communication to internal customers.
- Follow Good Documentation Practices (GDP) and maintain required training.
- Lead Analyst, R&D Technical Writing role within Sustaining R&D, focused on developing regulatory-compliant product labeling and documentation that meets business requirements and supports product lifecycle activities.
- Research and write clear, logical technical documents and test methods for reader comprehension.
- Contribute to quality improvement initiatives including NCs and CAPAs.
- Prepare for audits by compiling documentation and interacting with auditors.
- Manage compliance and recertification projects, including coordination of stakeholders and design adjustments.
Skills:
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Visio).
- Skilled in Adobe Creative Suite (InDesign, FrameMaker, Photoshop, Illustrator).
- Experience with database-driven labeling systems (Prisym ID, Label View, Loftware, Bartender, Nice Label, Easy Label).
- Website design and testing experience.
Education and Experience:
- Bachelor’s degree in Graphics, Language, or related field, or equivalent experience (Advanced degree may reduce required experience).
- 4-6 years of relevant experience in technical writing or labeling.
- strong attention to detail, time management, and ability to handle multiple priorities under tight deadlines.
#LI-PK1
Qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
- Technical
- Labeling
- Compliance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County’s Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
To apply for this job please visit www.randstadusa.com.