Quality Control Manager

Quality Control Manager responsible for managing Quality Control personnel and ensuring the department meets regulatory and company requirements. Oversees areas such as incoming material inspection, device history records, and nonconforming material/product process. Provides QC support and expertise during Health Authority Inspections. Manages QC team members' performance, reviews, and development/training plans. Prepares and maintains data and reports on QC activities. Reviews document changes, engineering change requests, and labeling. Maintains current knowledge of domestic and international QA/QC regulations, guidelines, and standards. Participates in compliance activities and writes/revises departmental SOPs/qualifications/validations as required. Travels to other STAAR facilities as needed.

Requirements

• Bachelor's degree in a scientific field
• Minimum 3-5 years' experience in an FDA-regulated environment
• Knowledge of chemistry and microbiology assays
• Strong statistical, analytical, and data-processing skills
• Excellent written and oral communication, and technical writing and editing skills
• Ability to manage and prioritize multiple projects and organize departmental resources to meet business objectives
• Attention to detail