Quality Documentation Specialist — ISO 13485 & FDA Focus

Agiliti; Corona (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Agiliti is seeking a Manufacturing Documentation Specialist to join our Corona, CA site and lead QMS documentation efforts. You will author and manage documentation, training materials, and SOPs, ensuring alignment with regulatory standards and product quality.

The role requires coordinating with engineering, quality, regulatory, and manufacturing teams, maintaining audit trails, and supporting ISO 13485 compliance. Onsite, Monday–Friday, 8 am–5 pm, with a focus on patient safety and quality.

Qualifications

• Knowledge of internal and external audit.
• ISO 13485 experience preferred.
• Proficient computer skills in MS Office Suite and in an electronic ERP system.
• Ability to sit, stand, lift, bend and stoop numerous times throughout the day.
• Technical Writing experience preferred.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Management System, Quality Policy and all other documented quality processes and procedures.

Responsibilities

• Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency and CAPAs.
• Explain scientific and technical ideas by authoring clear and concise QMS documents, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
• Participate in the creation and maintenance of Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
• Assist in internal and external ISO 13485 audits of QMS
• Monitor governmental and associated industry organizations’ standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
• Processing Documentation: Routing and tracking Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) through the company’s system.
• System Updates: Entering and updating part numbers, Bills of Materials (BOMs), and item assemblies in Product Lifecycle Management (PLM) or Enterprise Resource Planning (ERP).
• Compliance & Traceability: Ensuring all changes comply with FDA 21 CFR Part 821/820 and ISO 13485 standards by maintaining exhaustive audit trails and updated Device Master Records (DMRs).
• Cross-Functional Coordination: Acting as a liaison between engineering, quality assurance, regulatory affairs, and manufacturing teams to ensure everyone is aligned on product revisions.
• Notification and Distribution: Distributing updated blueprints, standard operating procedures (SOPs), and work instructions to affected departments.

Skills

Audit knowledge

ISO 13485 experience

MS Office & ERP systems

Technical writing

Patient safety & quality

Education

Bachelor's degree in life sciences, engineering or technical communications

Job description

Agiliti is seeking a Manufacturing Documentation Specialist to join our Corona, CA site and lead QMS documentation efforts. You will author and manage documentation, training materials, and SOPs, ensuring alignment with regulatory standards and product quality.

The role requires coordinating with engineering, quality, regulatory, and manufacturing teams, maintaining audit trails, and supporting ISO 13485 compliance. Onsite, Monday–Friday, 8 am–5 pm, with a focus on patient safety and quality.