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
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