QUALITY CONTROL INSPECTOR

Description

POSITION SUMMARY

The Quality Control Technician performs inspections, testing, and quality-related activities to ensure raw materials, in-process products, and finished medical devices meet established specifications, regulatory requirements, and company quality standards. This position follows established procedures and work instructions and exercises limited independent judgment within defined guidelines.

The Quality Control Technician will work closely with Manufacturing, Engineering and Quality personnel to identify and address quality issues while maintaining accurate and compliant quality records in accordance with ISO 13485, FDA regulations, and the company's Quality Management System (QMS) requirements.

Requirements

ESSENTIAL DUTIES AND 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 Good Documentation Practices (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.

QUALIFICATIONS

Education

· High school diploma or equivalent required.

· Associate degree in a scientific, technical, or engineering discipline preferred.

Experience

· Minimum one year of quality, manufacturing, laboratory, or related experience preferred.

· Experience in a regulated industry such as medical devices, pharmaceuticals, biotechnology, or life sciences preferred.

Knowledge, Skills, and Abilities

· 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.

· Strong attention to detail and organizational skills.

· Ability to communicate effectively both verbally and in writing.

· Ability to identify discrepancies and report findings objectively.

· Basic understanding of measurement tools such as calipers, micrometers, gauges, and other inspection equipment.

Physical Requirements

· Ability to stand and walk for extended periods.

· Ability to lift and carry up to 50 pounds periodically.

· Manual dexterity sufficient to handle small components and inspection equipment.

· Ability to visually inspect products and read detailed documentation.

Work Environment

· Medical device manufacturing and laboratory environment.

· May require use of personal protective equipment (PPE), cleanroom attire, or gowning.

· Exposure to manufacturing equipment and controlled environments.