Position Summary
The Quality Inspector is responsible for ensuring that medical devices and components meet internal specifications, industry standards, and regulatory requirements. This role is essential in maintaining product quality, reliability, and safety in compliance with FDA, ISO 13485, and cGMP standards.
Key Responsibilities
Inspect incoming materials, subassemblies, and finished products using visual, mechanical, and electronic methods.
Perform in-process and final inspections according to work instructions, control plans, and technical drawings.
Accurately document inspection results in quality records, inspection reports, and non-conformance reports.
Identify and escalate non-conformances, supporting root cause analysis and corrective actions (CAPA).
Verify calibration status of inspection and test equipment prior to use.
Support internal and external audits by preparing documentation and participating in activities.
Contribute to the development and improvement of inspection procedures and protocols.
Ensure compliance with Quality Management System (QMS) requirements, including FDA 21 CFR Part 820 and ISO 13485.
Participate in continuous improvement initiatives such as 5S, Lean, and Kaizen.
Qualifications
Required:
High school diploma or GED; associate degree or technical certification in quality, electronics, or manufacturing preferred.
2+ years of experience as a quality inspector in a regulated industry (medical devices preferred).
Strong understanding of mechanical drawings, GD&T, and use of inspection tools (calipers, micrometers, multimeters, etc.).
Familiarity with FDA regulations, ISO 13485, and cGMP.
Experience using ERP and QMS systems for documentation and tracking.
Strong attention to detail, communication skills, and problem-solving ability.
Preferred:
IPC certification (e.g., IPC-A-610).
Experience with imaging systems or similar technology.
Training in root cause analysis tools (5 Whys, Fishbone Diagram, etc.).
Working Conditions
Primarily in a manufacturing environment with exposure to production equipment and inspection tools.
Ability to lift up to 40 lbs and sit or stand for extended periods.
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