Prismatik

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.. Proficient knowledge of Good Manufacturing Practices for Medical Devices (GMP), and Good Documentation Practices (GDP).. 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.. Ability to work independently with minimal supervision and effectively contributes as a team player.. Ability to work independently with minimal supervision and effectively contribute as a team player.

technical writer

Essential Functions:
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.
Education and Experience:
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.
Special Requirements/Certification:
Minimum two (2) technical writing samples.
Knowledge, Skills, and Abilities:
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

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