IFU Technical Writer, Medical Packaging & Devices

Location: Fremont, California (Onsite)Job Type: W2 ContractCompensation Range: $35 - 43 per hourCella is seeking a Technical Writer to join the Packaging Research & Development team for our client, a leading medical technology company, for an onsite 11-month contract.This person will be part of Packaging R&D and is responsible for creating end-user regulatory compliant product labeling that will support business requirements. The specialist may contribute to new product development and design change activities in the areas of label design/release, development of artwork/images and development or improvement of processes for improved efficiency and compliance. This role will engage with and mobilize cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead/collaborate on continuous improvement initiatives or special activities having business impact.Responsibilities:Researches and builds knowledge about products, service, technology, test method and documents in the clearest, most logical way for greatest reader comprehension.Drives continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices.Prepares for internal and external audits by gathering records, supporting backroom, and providing explanation for design areas developed by self with auditor in the Front Room.Fully supports the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and supporting improvements that make it easier for the organization to maintain compliance in complex areas.Demonstrates extensive application of knowledge through delivery of high-quality deliverables (SOPs, technical literature and Work Instructions, engineering work product) to ensure continuity of content style that meets applicable standards and is appropriate for its intended audience.Strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes.As regulations change and quality systems are merged/aligned, executes the creation/refinement of department and quality system SOPs, Work Instructions, forms, and templates that have considerable graphical content with minimal supervision.Provides input to creation of training and communication materials that can be used by self or other staff to convey new or updated processes.Modifies existing and creates new Quality System documentation (work instructions, standing operating procedures, forms, checklists, and templates).Leads structured problem-solving initiatives to resolve complex technical issues and document within appropriate quality system documentation.Provides weekly summary of activities, creates project plans, prioritizes, and effectively communicates updates to customers.Follows Good Document practices (GDP) for all documentation created/reviewed and stays current on all required training for incumbent position.Qualifications:2-4 years of relevant experience.Bachelor's Degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience).Must have a high level of service and responsibility in managing a high and varied workload from internal customers and be comfortable working to tight timelines.Microsoft applications (Word, Excel, PowerPoint, and Visio).Adobe Suite (InDesign, Photoshop, and Illustrator).Demonstrated application using database driven labeling system such as Prisym ID, Label View, Loftware, Bartender, Nice Label, and/or Easy Label.Experience supporting IFU (instructions for use) development and release in PLM (product lifecycle management) for new product development and design changes in conjunction with product labeling to ensure congruency with strong attention to detail.Experience managing tasks related to IFU/ Literature printing suppliers and translation supplier.JOBID: 122025-119515#LI-CELLA#LI-CC1#PLEqual 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 Cella, a randstad digital company, 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 HRsupport@randstadusa.com.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, Cella by randstad digital 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.