Medical Device Quality Inspector: Precision & Compliance

TSE Industries Inc; Clearwater (FL); On-site; USD 42,000 - 56,000; Full time

Job summary

TSE Industries Inc. seeks a Quality Control Technician to perform inspections and testing to ensure materials, in-process products, and finished medical devices meet specifications and regulatory requirements.

The role supports quality records and adheres to ISO 13485, FDA regulations, and the QMS. Candidates should have strong attention to detail, document control skills, and the ability to work with cross-functional teams in a medical device environment.

Qualifications

• Understanding of quality inspection techniques and documentation practices.
• Ability to read and interpret procedures, specifications, drawings, and manufacturing records.
• Proficiency in basic computer applications, including Microsoft Office.

Responsibilities

• Perform incoming, in-process, and final inspections of materials, components, and finished medical devices.
• Review manufacturing documentation for completeness, accuracy, and compliance with approved procedures.
• Conduct dimensional, visual, functional, and other quality inspections using calibrated equipment.
• Record inspection and test results accurately and contemporaneously.
• Identify and document nonconforming materials, products, or processes.
• Assist in investigations related to quality issues, deviations, complaints, and nonconformances.
• Support material review activities and disposition processes as assigned.
• Verify labeling, packaging, and documentation compliance.
• Maintain inspection records in accordance with GDP.
• Participate in internal audits, quality improvement initiatives, and continuous improvement activities.
• Ensure compliance with applicable regulations, including 21 CFR Part 820, ISO 13485, and company procedures.
• Maintain a clean, organized, and safe work environment.
• Perform other duties as assigned.

Skills

Quality inspection techniques

Documentation practices

Attention to detail

Communication skills

Reading & interpreting procedures

Measurement tools knowledge

Education

High school diploma

Associate degree in science/technical/engineering

Tools

Microsoft Office

Job description

TSE Industries Inc. seeks a Quality Control Technician to perform inspections and testing to ensure materials, in-process products, and finished medical devices meet specifications and regulatory requirements.

The role supports quality records and adheres to ISO 13485, FDA regulations, and the QMS. Candidates should have strong attention to detail, document control skills, and the ability to work with cross-functional teams in a medical device environment.