QUALITY CONTROL INSPECTOR
About The Position
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. The position follows established procedures and work instructions and exercises limited independent judgment within defined guidelines. The technician works 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 requirements.
Requirements
- High school diploma or equivalent required.
- 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.
- 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.
Nice To Haves
- Associate degree in a scientific, technical, or engineering discipline.
- Minimum one year of quality, manufacturing, laboratory, or related experience.
- Experience in a regulated industry such as medical devices, pharmaceuticals, biotechnology, or life sciences.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
