Technical Writer
Description
- Partners with subject matter experts on specific company processes to research, compile, and edit documents for procedures or protocols relating to the dental industry.
- Creates Standard Operating Procedures (SOPs) for new procedures for Quality Management System incorporating requirements to meet 21CFR 820; maintains and updates current SOPs.
- Generates, updates, and maintains documents in response to regulatory feedback from internal and external reviewers including, but not limited to; standard operating procedures, forms, medical device and software development processes/protocols, technical reports, manufacturing instructions, user manuals and labeling documents compliant with style and formatting requirements for regulatory and quality standards and specifications.
- Creates technical submission files and in consultation with RA/QA on submission/approval process.
- Collaborates with RA/QA, R&D, engineers, management, and other subject matter experts to produce technical documentation for FDA-controlled medical devices; ensure compliance with established standards, product specifications, and regulations.
- Partners with subject matter experts in various departments to ensure accuracy of written documents as it regards to their area of expertise; which can include but is not limited to: scientific studies and tests, trademark, copyright, MSDS, etc.
- Studies, comprehends, summarizes, and accurately documents technical and scientific information/data/charts in detail.
- Writes copy in established format to meet specified deadlines.
- Submits documentation through Quality Management System using Good Documentation Practices.
- Supports the RA/QA team with action items, project planning and coordinates with RA/QA Quality Engineers for successful project/product launches.
- Performs other related duties and projects as business needs require, at direction of management.
- Bachelor’s degree in Technical Communications, Engineering or related field.
- Minimum of three (3) years of technical documentation experience.
- Previous experience in an FDA-regulated industry, a plus.
- Minimum two (2) technical writing samples.
- Ability to efficiently work as part of a team.
- Able to multi-task and manage multiple projects with various departments.
- Proficient use of Microsoft Office applications and authoring tools.
- Must be able to create training documentation for updated or changed procedures.
- Must be able to document task procedures through observation and demonstrations.
- Must be able to meticulously scrutinize work instructions to identify changes.
- Must be capable of learning and remaining up to date on new regulatory standards and procedures.
- Proficient knowledge of 21CFR820 and ISO 13485.
- Proficient knowledge of Good Manufacturing Practices for Medical Devices (GMP), and Good Documentation Practices (GDP).
- Knowledge of SOR-98-282 for Canada and ISO 14971 Risk Management a plus.
- Proficient knowledge of medical manufacturing device industry SOP guidelines.
- Proficient knowledge of performing and creating technical communication.
- Basic knowledge of photography.
- Ability to take photographs that properly display important visual aspects of SOPs.
- Ability to draft work instructions from notes, observations, and photographs.
- Rapid understanding of complex systems, both hardware and software, and ability to translate Ability to perform and/or support internal and/or external audits as required.
- Understanding of software development practices
- Ability to work independently with minimal supervision and effectively contributes as a team player.
- Ability to effectively prioritize and manage multiple tasks and available time.
- Demonstrated high standard of quality of work.
- Demonstrated attention to detail and accuracy.
- Ability to be dependable, reliable, and consistent in performing work.
- Ability to deliver quality results under high pressure deadlines in a fast-paced environment.
- Ability to work independently with minimal supervision and effectively contribute as a team player.
Pay: $ 30.81/hr-45.00/hr
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!
In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.
Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.