Primary Purpose & Essential Job Duties
The Device Document Control (DDC) Technical Writer is responsible for the creation and maintenance of written materials for FDA regulated devices, including Design Specifications, Technical Specifications, and User Manuals. This individual is responsible for maintaining a document’s content, generating final labeling, and distributing end-user labeling via Confluence. The individual in this role will create and adhere to high quality standards, as all device and product labeling are considered to be part of the FDA regulated devices developed by BBCS and must comply with very specific guidelines for management and availability. The role’s essential Job Duties are as follows:
- Ensure regulated device and product labeling meets both BBCS and FDA requirements through the utilization of defined Standard Operating Procedures (SOPs), Standards (STDs) and Guidelines.
- Support the BBCS change management system for all documentation updates.
- Support the device development process through being a key team member within the Software Development Life Cycle (SDLC) utilizing Agile methodologies.
- Ensure the device and product labeling aligns to the current product functionality and intended use.
- Ensure the device and product labeling is available to clients and staff as defined within the approved BBCS SOPs & STDs, with a high attention to version control.
Additional responsibilities may include:
- Supporting other DDC department objectives.
- Assist with conducting internal audits with QA to ensure compliance and improve processes.
Other Job Duties
As an employee within BBCS, this position will participate with the other staff members to contribute to and support the corporate goals, business plan, standard operating procedures and Corporate Quality Policy, and thus requires personal and professional integrity and work ethics.
Qualifications and Experience
- Strong written communication skills and attention to detail.
- Proficient with MS Office, especially Word.
- A working knowledge of software documentation from both a user and developer perspective.
- Experience in establishing and writing methods and standard operating procedures related to software documentation.
- Ability to multi-task and prioritize tasks related to project timelines.
- Experience working in a software development environment, regulatory, medical device or experience with QA testing.
- A BA/BS in technical writing or English, or equivalent experience.
Blood Bank Computer Systems, Inc. (BBCS) is located in Auburn, WA with a mission to serve the health care industry around the country through integrated technologies and unwavering support solutions. BBCS currently supports the blood and tissue industry in 18 states.
BBCS is looking for positive, passionate people to join our team. We offer competitive benefit packages including: Health Benefits, Profit Sharing, 401k matching, Paid Time Off, and the employee favorite half day Fridays during the summer.
The statements contained herein reflect general details as necessary to describe the principal functions of this job, the level of knowledge and skill typically required and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance the workload.