Technical Writer

Technical Writer

Hybrid 2 to 3 days a week in Mesa, AZ

Contract: 6 Months

Profile:

• Bachelor's Degree
• 3 years' experience in Technical Writing for Medical devices
• Strong understanding of ISO 13485, ISO 14971, FDA QSR - 21 CFR Part 820
• Good understanding of regulatory compliance for medical devices
• Ensure all documents conform to FDA requirements for GMP/QSR and ISO13485
• Professional experience writing technical documentation for both hardware and software in a FDA regulated environment
• Ability to read and interpret engineering drawings, design and risk documents, software requirements
• Bill of materials, system and components specifications, assembly instructions, and test documentation
• Exceptional written, organizational, inter-personal, project management, attention to detail and proofreading skills
• Proven ability to work independently and in teams
• Strong interpersonal, verbal communication, presentation skills and technical communication skills.

Key Responsibilities:

• Author, format, store, and update various technical documents, including Standard Operating Procedures (SOPs), Work Instructions, and Engineering Protocols (e.g., Installation Qualifications, Operational Qualifications, Performance Qualifications, and Test Method Validations).
• Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components.
• Manage all the existing and incoming equipment and ensure their documentation using the equipment binder.
• Perform risk assessments, investigate nonconformance issues, gap analysis, and develop corrective actions.
• Initiate and manage Change Requests and Change Orders to validate new and repaired equipment.
• Serve as the main focal point for the component system, including data collection, data validation, meeting coordination, rollout execution, and progress updates.
• Support Maintenance and Repair schedules with sufficient documentation for each piece of equipment.

STM Consulting, Inc is a fully owned subsidiary of Spectrum Talent Management

STM Consulting, Inc. provides comprehensive Professional Services and IT Outsourced services across North America, Canada, Mexico, UK, Middle East and India. The solutions we offer include Flexible Staffing, Managed Services, Contingent Recruitment, Contract Staffing, Executive Search, Global Recruitment, IT Staff Augmentation, On-boarding and Payroll.

Since our inception in 2008, we have grown tremendously and have been on the path of constant growth and enrichment. With a specialization in various domains of the recruitment industry, we cater to the staffing and recruitment needs of firms on a global scale. Owing to our substantial talent pool and a deep understanding of the recruitment industry, we have made significant strides in the HR market. From Payroll Management, RPO, Permanent Recruitment to Flexi Staffing, the values that we offer to our clients has developed and transformed over the years. Due to this, we are the preferred choice for most of the patrons globally.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.