Manufacturing Documentation Specialist

Responsibilities

• Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency and Corrective and Preventive Actions (CAPAs)
• Author clear and concise QMS documents, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
• Create and maintain Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
• Assist in internal and external ISO 13485 audits of QMS
• Maintain governmental and industry standards compliance by monitoring standards, guidelines, and policies
• Process Documentation: Route and track Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) through the company’s system
• System Updates: Enter and update part numbers, Bills of Materials (BOMs), and item assemblies in Product Lifecycle Management (PLM) or Enterprise Resource Planning (ERP)
• Ensure 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: Act as a liaison between engineering, quality assurance, regulatory affairs, and manufacturing teams to ensure everyone is aligned on product revisions
• Distribute updated blueprints, standard operating procedures (SOPs), and work instructions to affected departments

Requirements

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

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
• Sit, stand, lift, bend and stoop numerous times throughout the day
• Technical Writing experience preferred

Pay, Benefits, and Schedule

Pay Range for All Locations Listed: $59,022.27 - $94,457.18

This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. For sales positions, this range combines the base salary and the target incentive pay.

The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors.

Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation.

Primary Job Location: Corona CA

Additional Locations (if applicable):

Pay and Benefits: This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. For sales positions, this range combines the base salary and the target incentive pay. The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors. Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation.