Quality Inspector (ID #471226)

Quality Control Specialist

The Quality Control (QC) Specialist is responsible for ensuring that all orthopedic braces, casts, and related medical support devices meet company standards, regulatory requirements, and customer expectations. This role involves inspecting products at various stages of the manufacturing process, documenting results, identifying nonconformities, and supporting continuous improvement efforts to maintain the highest level of product quality and patient safety.

Key Responsibilities:

• Perform visual and dimensional inspections of incoming materials, in-process components, and finished products.
• Verify that all products meet established specifications, tolerances, and medical device quality standards.
• Conduct functional and mechanical tests on orthopedic braces and components as required.
• Maintain accurate and detailed inspection records, test data, and quality reports.
• Identify, document, and communicate nonconformances; assist with root cause analysis and corrective actions.
• Ensure compliance with FDA, ISO 13485, and company quality management system (QMS) requirements.
• Collaborate with production and engineering teams to address quality issues and implement improvements.
• Participate in internal audits, calibration checks, and equipment verification activities.
• Support training efforts related to quality procedures and inspection techniques.
• Promote a culture of continuous improvement and quality awareness across the organization.

Qualifications:

• High school diploma or equivalent required; associate or bachelor's degree in a technical or science-related field preferred.
• 2+ years of experience in quality control or assurance, preferably in a medical device or manufacturing environment.
• Knowledge of FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP).
• Strong attention to detail and analytical skills.
• Proficient with measuring tools (calipers, micrometers, gauges) and quality inspection equipment.
• Excellent documentation, communication, and teamwork skills.
• Ability to read and interpret technical drawings and specifications.

Work Environment:

• Manufacturing and inspection area; may require standing for long periods and handling of lightweight components.
• Strict adherence to safety and cleanliness standards in a medical device manufacturing setting.