Ref ID: 04835-0012138348
Classification: Technical Writer
Compensation: $60.00 to $65.00 hourly
One of Robert Half's Fortune 500 Medical Device clients is hiring a Technical Writer to support R& D efforts and new product launches. This will be a long-term contract opportunity with potential for extension.
If you have previous experience overseeing new product development and design change activities in a regulated environment, apply today!
100% ONSITE IN FREMONT, CA | 1+ YEAR PROJECT | $60-65/HR
Lead Analyst, R& D Technical Writing, as a part of Sustaining R& D, is responsible for creating end-user regulatory complaint product labeling that will support business requirements.
The specialist contributes to new product development and design change (sustaining) 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.
Essential Duties & 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
• Prepare 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
• Lead recertification and other compliance projects by managing key activities with stakeholders to execute required changes and sometimes determine alternate design directions
• Fully support 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
• Demonstrated 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
• Leads structured problem-solving initiatives to resolve complex technical issues and document within appropriate quality system documentation
• As regulations change and quality systems are merged/aligned, execute 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
• Experienced in modifying existing and creating new Quality System documentation (work instructions, standing operating procedures, forms, checklists, and templates)