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Senior Technical Writer

Milwaukee, Wisconsin

Job ID: 9102 Category: Professional

Job Description

  • The Senior Technical Writer will be supporting a key program in Milwaukee, WI. The Quality System Improvement plan is the company’s highest priority to ensure compliance is maintained and sustainable for the future.
  • This person will work closely with the Engineering, Marketing, Service, Regulatory and Quality organizations to create and manage various Quality System procedures.
  • These documents will be generally intended for disclosure to internal customers.
  • Duties include team management, content creation, editing and formatting documents per established style guidelines, participating in the formal review and approval of such documents and publications.
  • Editing a variety of documentation including SOPs, Work Instructions, Job Aids, Training Material, and Forms.
  • Ensuring documentation content is of high quality and conforms to standards (CFR 820, ISO 13485, Medical Device Directive).
  • Editing and improving existing documentation in line with project standards.
  • Ensuring effective document and file management across the project.
  • Experience with document structure and logic flow, as well as writing for non-technical audiences.
  • Excellent written and oral communications skills.
  • Must be able to effectively interface with Subject Matter Experts and mid-level management.
  • Strong collaboration skills
  • Ability to research and organize process work steps in a concise and discernible manner.
  • Ability to manage multiple assignments while ensuring technical accuracy, adherence to documentation standards, and a timely delivery of all work products.
  • Participate in planning and scheduling of work efforts.
  • Schedule and prioritize work efforts to meet deadlines; stores and organizes electronic files.
  • Assist in the preparation, processing and control of other documents, as needed.
  • Responsible for ensuring department is properly staffed, identifies top performers/underperforming employees and develop appropriate plans for development, actively engages and motivates employees.
  • Perform other duties as requested.

 

Qualifications:

  • BA/BS or equivalent four-year degree in English, journalism, communication or a technical field and/or equivalent work experience, Master’s Degree is preferred.
  • 5+ years relevant work experience in a regulated environment, preferably within the medical industry.
  • Significant experience and expertise in writing Quality procedures for a regulated company, preferably within medical industry.
  • Experience developing new and/or refinement of existing technical writing processes to enhance quality and productivity
  • Ability to write instructional materials for a professional audience as well as technicians and specialists.
  • Highly proficient in the use of Microsoft Word.
  • Working knowledge of other Microsoft Office tools such as Excel, PowerPoint, Outlook, etc.
  • Working knowledge of graphics applications such as Adobe Illustrator, Adobe Photoshop, Adobe Framemaker, Adobe Acrobat, etc.
  • Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems.
  • Excellent verbal and written communication skills, with expert command of the English language.
  • Familiarity with technical terms pertaining to medical devices.
  • Able to coordinate multiple activities and actions of persons contributing to assigned tasks.
  • Detail oriented with good organizational and record keeping skills.
  • Excellent written and verbal communication skills, along with the ability to work independently and as part of a cross-functional team.
  • Proactive and timely in execution of assigned tasks.
  • Able to be flexible and adaptable when needs and priorities change.
  • Work experience with similar responsibilities at a medical device company.
  • Managerial experience preferred.
  • Familiarity with regulatory requirements of medical devices.
  • Proficiency with desktop publishing software.
  • Excellent interpersonal and verbal/written communication skills.
  • Ability to manage time and prioritize work.
  • Must possess outstanding customer service skills.
  • Must possess strong decision making and problem solving skills.
  • Must be able to work with minimal direction, be highly motivated, and be a team player.
  • Advanced Microsoft Office skills including: Work, Outlook, Excel and PowerPoint.
  • Demonstration of leadership competencies such as: effective planning, motivating and developing staff and building effective teams.
  • Comfortable working with ambiguity and change. Must be able to work in a fast pace environment.
  • Must be a team-player, possess outstanding customer service skills and be self-motivated.
  • Acts with a sense of urgency, illustrates ambition, and drives for completion of tasks and projects.
  • Must have the ability to initiative and develop creative solutions.
  • Possess the ability to manage time and prioritize critical priorities.
  • Must demonstrate the ability to increase knowledge.

 

Physical demands and work environment:

Physical Demands: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone.

 

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