Job Description

The Quality Inspector I is responsible for performing inspections and quality assurance activities to ensure that raw materials, in-process components, and finished medical device products meet established specifications and regulatory requirements. This role supports compliance with FDA Quality Management System Regulations (QMSR), 21 CFR Part 820, ISO 13485, and company quality standards by executing inspection protocols, documenting results, and identifying nonconformances.

• Perform inspection and testing activities on incoming materials, in-process components, and finished goods in accordance with approved procedures, specifications, and sampling plans.

• Conduct visual, dimensional, and functional inspections using calibrated measuring instruments (e.g., calipers, micrometers, gauges) and test equipment.

• Review and verify Device History Records (DHRs), batch records, and other quality documentation for completeness, accuracy, and compliance.

• Identify, document, and escalate nonconforming materials or products in accordance with established procedures; support material segregation and containment activities.

• Initiate and/or support nonconformance reports (NCMRs) and assist in investigations as required.

• Perform in-process and final audits to ensure adherence to manufacturing procedures and quality standards.

• Accurately record inspection and test results in electronic and/or paper-based systems in compliance with Good Documentation Practices (GDP).

• Support line clearance activities and verify readiness for production runs.

• Collaborate cross-functionally with Manufacturing, Engineering, and Quality Engineering to address quality issues and support continuous improvement initiatives.

• Ensure compliance with applicable regulatory requirements including FDA 21 CFR Part 820, ISO 13485, GMP, and internal procedures.

• Maintain inspection equipment and ensure calibration status is current prior to use.

• Follow all safety, cleanliness, and contamination control practices, including cleanroom procedures where applicable.

• Support internal audits, external regulatory inspections, and customer audits as needed.

• Perform other duties as assigned.

Knowledge, Skills and Abilities:

• Working knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and basic quality system requirements.

• Familiarity with FDA 21 CFR Part 820 and/or ISO 13485 standards preferred.

• Ability to read and interpret engineering drawings, specifications, procedures, and inspection criteria.

• Proficiency in the use of basic inspection tools and measurement equipment.

• Strong attention to detail and ability to detect defects and deviations.

• Basic understanding of sampling plans and inspection methods.

• Effective written and verbal communication skills.

• Basic computer skills (e.g., Microsoft Office, electronic quality systems).

• Ability to work independently and as part of a team in a fast-paced, regulated environment.

• Strong organizational and multitasking abilities.

Work Environment:

• Production/Clean Room/Warehouse/Office environment which may require long periods of sitting, standing, or getting up and down throughout the day.
• Occasional lifting up to 35 pounds.
• Adherence to gowning and cleanroom requirements may be required.

Experience:

• 1+ years of experience in a quality, manufacturing, or regulated environment.

Education:

• Secondary Education degree preferable or 9th Secondary grade.

• Quality-related certifications (e.g., ASQ Certified Quality Inspector) are a plus.

• Basic proficiency in English (reading, writing, and comprehension) preferred.