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Senior Technical Writer
As an integral part of the Quality team, the Senior Technical Writer will be responsible for creating and editing quality system documents such as, standard operating procedures, work instructions, forms, templates, training documents and presentations, technical dossiers, regulatory submission documents, instructions for use, surgical techniques, etc. The Senior Technical Writer must ensure documents are clear, concise, and accurate in conveying information to the user while maintaining compliance with the Quality Management System (QMS) and applicable standards and regulations. This position is responsible for the coordination, implementation, and maintenance of the company’s Document Change Control systems. It supports both SpineFrontier and its sister companies.
Working with subject matter experts, develops high-quality QMS documents, presentations, technical dossiers, and publications, etc. for a wide range of uses.
Ensures content is written appropriately for the audience, communicates instruction clearly, and conforms to industry standards. Understands interrelationship of documents and processes.
Upholds company writing standards and continues to strive for excellence in deliverables.
Completes document control and technical writing quality checks. Reviews documents for appropriate references. Edits and rewrites documents as necessary.
Follows documents through their approval cycle, annual review, through archival within CompliantPro (EDMS).
Manages writing assignments and provides regular updates to stakeholders on project status.
Assist in the administration of the training system in CompliantPro; setting up users and exams as required.
Supports the Document Control/record management function. Supports user requests for documentation and trains users in CompliantPro
Heavy contributor to administration/maintenance of CompliantPro
Investigates and responds to corrective actions related to Document Control, Training and External Standards.
Assist in supporting external audits, coordinating activities in backroom and ensuring timely response to documentation requests for auditors.
Assists with GAP analysis when regulations change.
Other duties may be assigned as deemed necessary by the supervisor
2-3 years of medical device technical writing experience
Demonstrated skills in technical writing; grammar and usage, form, organization of ideas, technical communications.
Ability to manage multiple documentation projects in a fast-paced environment.
Strong time management skills; independent worker.
Mastery of MSWord. Good understanding of PowerPoint, Excel, Visio, and Adobe standard
Bachelor's Degree in a related discipline.
Must be able to work within an EDM system
Working knowledge of ISO 13485 and 21 CFR 820
Comfortable in a start-up environment where process and role structure is frequently missing or changes rapidly.
Well acquainted with the Chicago Manual of Style
This position operates in a mainly clerical setting. Routinely uses standard equipment, computer, telephones, photocopiers, filing cabinets etc.
Sitting for extended periods of time using a computer keyboard and monitor
The position frequently requires objects to be moved from one place to another under 5 pounds lifting is periodically needed in order to move files.
This person frequently communicates with employees. Must be able to read, write and communicate to exchange accurate information in these situations.
Must be able to read, write and communicate fluently in English.
Worker is required to have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
Worker is required to have close visual acuity to perform and analyzing data and figures, viewing a computer terminal; extensive reading at a distance that is close to the eyes
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
How to apply
We offer tremendous room for advancement and income potential. All submissions will be held in the strictest confidence. This position is being sought after for immediate hire. The company is an Equal Opportunity Employer.
Please no outside unsolicited recruiters