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 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.)

This is an onsite role, based in Corona California with the general work hours of Monday – Friday, 8 am – 5pm.

Additional Responsibilities:

• 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.

Required Experience –

• Bachelor’s degree in life sciences, engineering or technical communications strongly preferred.
• 3-5 years Quality or other applicable experience

Required

Skills and Abilities

• 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.

Disclaimer

This job description in no way states or implies that these are