First Article Inspector

First Article Inspector Position Overview:

Responsible for performing First Article Inspections, ensuring production readiness, and verifying compliance with specifications, procedures, and regulatory requirements. The role serves as a quality gate for product and documentation release, enforces Good Documentation Practices (GDocP), and initiates and supports the control of nonconforming material to ensure product quality, traceability, and compliance with GMP and

ISO 13485

standards.

Responsibilities:

First Article Inspection (FAI) & Production Release

• Perform First Article Inspections on medical devices and packaging at assembly, cleanroom packaging, and final packaging stages
• Conduct independent second verification and approve production continuation
• Verify line clearance, workstation readiness, and segregation of production orders
• Review and confirm accuracy of production orders and batch records
• Verify product identification (LOT, article number, size, traceability)
• Inspect assembly processes, tooling, functional testing, and product condition
• Verify packaging materials, labeling, positioning, and configuration
• Confirm equipment settings (sealing, cutting, vacuum, oxygen where applicable)
• Perform label reconciliation and packaging verification during final packaging
• Document results and release production steps in the Batch Record. Final Administrative Inspection & Documentation Release
• Perform final administrative inspection of production orders and sterilization certificates
• Verify completeness, correctness, and proper sequencing of all documentation
• Ensure all required records, forms, and supporting documents are included
• Confirm all entries are completed, signed, dated, and compliant
• Review sterilization records, certificates, and traceability elements
• Approve or reject documentation packages prior to archiving
• Ensure proper scanning and archiving of approved records
• Has authority to approve or reject production documentation for final release and archiving Good Documentation Practice (GDocP) Enforcement
• Ensure compliance with Good Documentation Practices across all records
• Verify all entries are: Ø Accurate, complete, and legible Ø Attributable (signed and dated by performer) Ø Recorded in real time
• Enforce proper correction practices (single-line strikeout, signed, dated)
• Ensure no prohibited practices (white-out, backdating, overwriting, pencil use)
• Verify traceability: who performed what, when, and how
• Ensure raw data is properly maintained, protected, and retrievable
• Reject documentation that does not meet GDocP requirements Nonconforming Material Control
• Identify and initiate Nonconformance Reports (US-4540FO003) for defects
• Provide detailed description, source, and containment actions
• Segregate and control nonconforming material using Blocked Goods Form
• Prevent use or release of nonconforming product without authorization
• Support evaluation, investigation, and root cause analysis.

Support execution and verification of disposition (rework, scrap, UAI, return) General Responsibilities

• Maintain compliance with cleanroom, GMP, and hygiene requirements
• Ensures full traceability of product, materials, labeling, and documentation.
• Communicate quality issues to Production, QA, and Engineering
• Support continuous improvement and process optimization
• Maintain a clean, organized, and inspection-ready work environment Perform other duties as assigned

Preferred Knowledge, Skill, and Abilities:

• Strong attention to detail and quality awareness
• Ability to enforce compliance and make independent quality decisions
• Knowledge of GDocP and data integrity principles
• Ability to manage documentation review and release activities
• Strong communication and problem-solving skills
• Ability to work in cleanroom environments
• Ability to handle small components and perform detailed inspection work Basic computer skills (QMS, ERP systems) What we

Offer:

• Hands-on experience in a growing international company in the Medical Device sector
• Structured onboarding, mentoring, and career development opportunities.
• Exposure to regulatory audits, QMS certification processes, and cross-functional projects
• Opportunity to contribute to the continuous improvement of processes that directly impact patient safety.

Job Type:

Full-time Pay:

$25.00 - $30.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Education:

Bachelor's (Preferred)

Experience:

ISO 13485

3 years (Required)

Work Location:

In person