Senior Quality Control Inspector

Senior Quality Control Inspector

This role is responsible for performing precise mechanical inspections, maintaining compliance with FDA and ISO 13485 standards, and partnering with cross-functional teams to ensure product quality and integrity throughout the manufacturing process.

Responsibilities

• Perform dimensional, visual, and functional inspections of components, subassemblies, and finished assemblies
• Conduct First Article (FAI), in-process, final, and RMA inspections
• Maintain calibrated equipment in the Quality Control Lab and assist with internal calibrations
• Generate and maintain part-specific inspection forms and quality documentation
• Support inspection activities for R&D projects and new product development
• Interpret engineering drawings, specifications, and GD&T symbols to verify compliance
• Document and process non-conforming issues and support investigations
• Provide inspection records for internal and external audits
• Collaborate with suppliers for technical information and product verification
• Participate in continuous improvement efforts to enhance accuracy and efficiency

MUST HAVES:

• High school diploma or equivalent
• Minimum 7 years of experience in Quality Control; medical device experience a plus
• Strong background in mechanical inspection, calibration, and metrology
• Proficient in interpreting GD&T and mechanical drawings
• Skilled in using inspection tools such as calipers, micrometers, microhite, pin gages, and thread gages
• Familiar with ERP/MRP systems and electronic quality management systems (eQMS)
• Basic understanding of IPC standards for inspections