Senior Technical Writer
- 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.
- 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.