Senior Technical Documentation Specialist
About The Position
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. The role develops, revises, coordinates, and drives technical and quality-system documentation while ensuring compliance with company procedures and quality requirements. The specialist partners with technical teams to convert technical inputs into clear, accurate, compliant documentation and uses AI-enabled tools and automation to improve quality, consistency, and execution speed. The position is based on-site at Biolinq’s headquarters in San Diego, California, primarily in an office and laboratory environment. Occasional travel, up to 10%, may be required to support development activities. Success is measured by the quality and compliance of documentation, timely completion of review and release activities, effective coordination among stakeholders, independent follow-through, and effective use of AI-enabled tools and emerging technologies.
Requirements
- Bachelor's degree or equivalent professional experience.
- At least 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 demonstrated ability to apply them to technical documentation, process improvement, and workflow automation.
- 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.
Nice To Haves
- Experience in a medical device, biotechnology, pharmaceutical, aerospace, or other highly regulated industry.
- Experience supporting product development teams, such as engineering, manufacturing, quality, or regulatory teams.
- 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, or documentation records, such as DHRs, MPIs, BRs, NCMRs, and COs.
- Familiarity with FDA Quality System Regulation, ISO 13485, and related quality frameworks.
Responsibilities
- Develop, revise, and maintain technical, manufacturing, and quality-system documentation.
- Prepare documentation using 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 manufacturing instructions and records, test documentation, technical reports, change-control records, quality records, and risk-management documentation.
- Ensure documentation complies with applicable procedures, templates, and quality-system requirements.
- Review documentation for accuracy, completeness, consistency, traceability, and clarity, and verify that it reflects approved technical content and processes.
- Coordinate and drive documentation through review, approval, and release workflows.
- Track documentation status and proactively follow up with stakeholders.
- 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.
- Translate technical information into clear, audience-appropriate documentation.
- Use 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Health savings account
- Flexible spending account
- Life insurance
- Long-term disability insurance
- 401(k) plan
- Holidays
- Paid time off, including vacation and sick time
- Parental leave
- Annual performance bonus and/or other applicable incentive compensation plans
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What This Job Offers
Job Type
Full-time
Career Level
Senior
