Senior Technical Documentation Specialist

Biolinqorporated • San Diego, CA

1d • Onsite

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. It partners with technical teams to turn technical inputs into clear, accurate, and compliant documentation, using 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, in an office and laboratory environment. Occasional travel of up to 10% may be required.

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.
• 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.

Nice To Haves

• Experience in medical device, biotechnology, pharmaceutical, aerospace, or another 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, and documentation, including 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 documents 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 documents comply 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 documents through review, approval, and release workflows; track status and follow up with stakeholders.
• Identify and resolve documentation bottlenecks, administrative obstacles, and documentation gaps, partnering with accountable owners as needed.
• Partner with cross-functional teams to support timely review, approval, and release of documents.
• Manage multiple documentation activities 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 and independently drive activities to completion.

Benefits

• Medical, dental, and vision insurance
• Health savings account
• Flexible spending account
• Life and 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 may be included in the total compensation package

What This Job Offers

• Job Type: Full-time
• Career Level: Senior