Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far-reaching consequences, and require sensitivity, tact and a clear dedication to service. It’s about providing clarity and hope.
As a Bioinformatics Software Technical Writer, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing.
This on-site position is based from our San Juan Capistrano, CA location.
Bioinformatics Software Technical Writer – the role:
The Bioinformatics Software Technical Writer will coordinate the development of technical documents supporting new advanced diagnostics product releases in a clinical diagnostics environment. This professional is responsible for working with subject matter experts to create, write, and edit technical documentation while ensuring compliance with regulatory requirements.
The Bioinformatics Software Technical Writer will work with QA/Regulatory, IT, and other business partners to identify and implement improvements in the documentation process and streamline content creation. Required documentation will include development, verification, and validation plans, software requirements and specifications, test plans, test reports, and SOPs.
Work with Bioinformatics, Software Development teams, and other business partners to plan, write, and edit technical documentation for a variety of audiences including SQA, Clinical Quality / Regulatory, Lab Operations, R&D, and IT Operations.
Generate documents that meet appropriate quality standards to support formal validation and operational activities.
Develop and edit Standard Operating Procedures (SOPs), training materials, and user manuals.
Work with business partners to lead and implement improvements to the document creation process and content.
Contribute to the development of test plans.
Coordinate and maintain organized records of all supporting materials, document drafts, and versions.
Contribute to the success of projects in support of product development activities.
Impact the ability of the project team to meet assigned goals.
To qualify, the ideal candidate will have the following skills and experience:
5+ years of experience in technical writing of software and system documentation
Experience producing documentation for validated medical systems and providing evidence of compliance with legal, business and regulatory requirements such as FDA 21CFR11, CAP/CLIA, or ISO 15189
Bachelor’s degree, preferably in Technical Writing, Communications, Information Technology, Engineering, or Science
Background knowledge of Molecular Biology or Molecular Genetics
Excellent written and verbal communication skills
Strong attention to detail
Proficiency in MS Office
Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.
Your Quest career. Seek it out.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity.
Internal Number: req33646
About Quest Diagnostics
We are an industry leader with a longstanding reputation for exceptional quality and stability in our market. We inspire action, illuminate answers, and advocate better health.
At Quest Diagnostics, we are dedicated to continuously improving patient health. We are the world’s leading provider of diagnostic testing, services, and information that patients and doctors rely on to make better healthcare decisions.
Each day, we impact the lives of millions, serving one in three American adults. Our continuous pursuit to discover and innovate enables us to create new solutions every day, many of which are now industry standards of care. Diagnostic tests influence about 66% of clinical decision making.