Manufacturing Documentation Specialist

Manufacturing Documentation Specialist

Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency, and Corrective and Preventive Actions (CAPAs). Explain scientific and technical ideas by authoring clear and concise QMS documents, training materials, user guides, internal communications, and customer letters through structured writing and content management.

Participate in the creation and maintenance of Management Review materials, including oversight and reporting of Quality Indicators (QIs)/metrics.

Assist in internal and external ISO 13485 audits of QMS.

Monitor governmental and industry 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 820 and ISO 13485 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.
• Notification and Distribution: distributing updated blueprints, SOPs, and work instructions to affected departments.

• Bachelor’s degree in life sciences, engineering, or technical communications strongly preferred.

• 3-5 years of quality or other applicable experience.

• Knowledge of internal and external audit ISO 13485 experience preferred.
• Proficient computer skills in MS Office Suite and an electronic ERP system.
• Ability to sit, stand, lift, bend, and stoop numerous times throughout the day.
• Technical writing experience preferred.
• Commitment to patient safety and product quality, maintaining compliance with QMS, Quality Policy, and all documented quality processes and procedures.

Primary:
Corona, California. Onsite. Work hours Monday – Friday, 8am – 5pm.

Health insurance options (Medical, Dental & Vision), Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Savings Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.

Pay range for this position: $59,022 – $94,457. Base salary plus potential short- or long-term incentives.

Agiliti is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, reasonable accommodations are available for qualified individuals with disabilities.