Senior Technical Documentation Specialist

Description

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The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers . While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.

About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Job Purpose

Biolinq is seeking a highly organized, detail-oriented, and technically proficient Senior Technical Documentation Specialist to support R&D, Operations, Manufacturing, and Quality teams throughout the product development lifecycle.

This role is responsible for developing, revising, coordinating, and driving technical and quality system documentation while ensuring compliance with company procedures and quality requirements. The Technical Document Specialist serves as a key partner to technical teams by converting technical inputs into clear, accurate, and compliant documentation while leveraging AI-enabled tools and automation to improve quality, consistency, and execution speed.

The ideal candidate possesses strong written communication skills, exceptional attention to detail, and the ability to translate technical concepts for diverse stakeholders. This individual thrives in a fast-paced environment, manages multiple priorities simultaneously, and proactively drives documentation activities to completion.

This position is based on-site at Biolinq's headquarters in San Diego, California.

Duties and Responsibilities:

Documentation Development

• •Develop, revise, and maintain technical, manufacturing, and quality system documentation.
• •Prepare documentation from technical discussions, design reviews, test data, stakeholder input, and other sources.
• •Collaborate with subject matter experts to gather information, resolve ambiguities, and ensure documentation accuracy.
• •Support documents such as manufacturing instructions and records, test documentation, technical reports, change-control records, quality records, and risk-management documentation.

Documentation Quality and Compliance

• •Ensure compliance with applicable procedures, templates, and quality-system requirements.
• •Review documentation for accuracy, completeness, consistency, traceability, and clarity.
• •Verify that documents accurately reflect approved technical content and processes.

Coordination and Execution

• •Coordinate and drive documentation through review, approval, and release workflows.
• •Track documentation status and proactively follow up with stakeholders as needed.
• •Identify and resolve documentation bottlenecks and administrative obstacles.
• •Partner with cross-functional teams to support timely document review, approval, and release.
• •Manage multiple documentation activities simultaneously while maintaining quality and responsiveness.

Systems and Process Support

• •Translate technical information into clear, audience-appropriate documentation.
• •Effectively leverage AI-enabled tools and automation to research, draft, review, improve, and streamline documentation and related business processes.
• •Build effective working relationships across functions.
• •Identify documentation gaps and partner with accountable owners to resolve them.

Key Success Factors

Success in this role is measured by:

• •High-quality, compliant documentation with minimal review findings or rework.
• •Timely completion of review, approval, and release activities.
• •Effective coordination across multiple assignments and stakeholder groups.
• •Ability to independently gather information and drive activities to completion.
• •Effective application of AI-enabled tools and emerging technologies to improve documentation quality, consistency, efficiency, and stakeholder productivity.

Requirements

Qualifications

• •Bachelor's degree or equivalent professional experience.
• •3+ years of experience in technical documentation, quality systems, manufacturing, engineering support, project coordination, or a related discipline.
• •Outstanding written, verbal, and interpersonal communication skills.
• •Exceptional attention to detail and organizational skills.
• •Advanced proficiency with AI-enabled productivity tools and a demonstrated ability to apply them effectively to technical documentation, process improvement, and workflow automation.
• •Proven ability to manage multiple concurrent projects and priorities.
• •Strong analytical and problem-solving abilities.
• •Ability to quickly learn technical concepts and processes.
• •Proficiency with Microsoft Office applications and document management systems.

Preferred:

• •Experience within a medical device, biotechnology, pharmaceutical, aerospace, or other highly regulated industry.
• •Experience supporting product development teams (e.g., engineering, manufacturing, quality, regulatory, etc.)
• •Demonstrated ability to adopt new technologies and drive process improvements in a fast-paced product development environment.
• •Familiarity with Quality Management Systems and design control requirements.
• •Experience with eQMS and document control systems.
• •Experience with manufacturing, quality, test, documentation (e.g., DHRs, MPIs, BRs, NCMRs, and COs).
• •Familiarity with FDA Quality System Regulation, ISO 13485, and related quality frameworks.

Working Conditions

• •Primarily based on-site, in an office and laboratory environment
• •Occasional travel (up to 10%) may be required to development activities

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands and fingers; manipulate office equipment, including a personal computer; handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office and/or manufacturing environment. Employee may occasionally lift/or move up to 50 pounds.

BENEFITS

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal

Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.

As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency inter