Quality Assurance Technician

About the role

Responsible for performing quality control inspections and tests on medical devices and components to ensure compliance with quality standards and regulatory requirements.

Responsibilities

• Conduct in-process, final, and incoming inspections of materials, components, and finished medical devices according to established procedures and specifications.
• Perform various tests, including visual inspections, dimensional measurements, functional tests, and material verification.
• Document inspection and test results accurately and completely, identifying and reporting non-conformances.
• Initiate Non-Conformance Reports (NCRs) and assist in the investigation and disposition of non-conforming materials.
• Utilize and maintain quality control tools and equipment, including calipers, micrometers, gauges, and other specialized testing apparatus.
• Support root cause analysis and corrective/preventive action (CAPA) activities as needed.
• Assist in the development and revision of inspection procedures and quality documentation.
• Adhere to all safety protocols, Good Manufacturing Practices (GMP), and quality system regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
• Collaborate with production, engineering, and R&D teams to resolve quality issues.
• Participate in internal and external audits as required.

Requirements

• High school diploma or GED required; Associate's degree in a technical field preferred.
• 1–3 years of experience in a quality control or quality assurance role, preferably within a regulated industry (e.g., medical device, pharmaceutical).
• Strong understanding of quality control principles and methodologies.
• Proficiency in reading and interpreting blueprints, schematics, and technical specifications.
• Experience with various measurement tools and techniques (e.g., calipers, micrometers, gauges).
• Familiarity with Good Manufacturing Practices (GMP) and relevant quality system regulations (e.g., ISO 13485, FDA 21 CFR Part 820) is a plus.
• Excellent attention to detail and strong analytical skills.
• Ability to accurately document and maintain records.
• Basic computer skills, including proficiency with Microsoft Office Suite.
• Good communication and interpersonal skills, with the ability to work effectively in a team environment.
• Ability to lift up to 25 pounds and stand for extended periods.

Schedule

• Primary Work Location: USA TX – El Paso – Northwestern Dr.
• Work Shift: US BD 2nd Shift 2 pm–10 pm (United States of America)