Current jobs related to Technical Writer - Irvine - Prismatik

**Essential Functions**:

- 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.
- 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.
- 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 mínimal 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 mínimal supervision and effectively contribute as a team player.

**Pay: $ 30.81/hr-45.00/hr