Cleanroom Quality Inspector

Overview

We are seeking a meticulous and dedicated Cleanroom Quality Inspector to join our advanced manufacturing team. This role is vital in ensuring that all products meet stringent quality standards within a controlled environment, adhering to regulatory and legal compliance requirements. The ideal candidate will possess strong mechanical knowledge, expertise in precision measurement, and familiarity with industry standards such as ISO 13485, ISO 9001, and FDA regulations. As a key contributor to our quality assurance processes, you will uphold the integrity of our cleanroom operations and support continuous improvement initiatives.

Responsibilities

• Conduct detailed inspections of components and finished products within the cleanroom environment using precision measuring instruments such as calipers, micrometers, height gauges, and vision inspection systems.
• Interpret mechanical blueprints and technical drawings accurately to verify conformance to specifications.
• Utilize coordinate measuring machines (CMM) to perform dimensional analysis and ensure measurement accuracy.
• Perform quality audits in accordance with ISO 13485, ISO 9001, and other relevant standards to maintain compliance.
• Collect and analyze data related to quality metrics, documenting findings systematically for review.
• Ensure manufacturing processes adhere to regulatory standards including FDA regulations, CGMP (Current Good Manufacturing Practices), HACCP (Hazard Analysis Critical Control Point), and other legal requirements.
• Support calibration activities for precision measurement tools and maintain calibration records.
• Assist in root cause analysis for quality issues and recommend corrective actions.
• Participate in cross-functional teams to improve quality systems and manufacturing workflows.
• Maintain a clean, organized work environment consistent with cleanroom protocols.

Qualifications

• Proven experience in quality inspection or quality assurance within manufacturing environments, especially those involving medical devices or pharmaceuticals.
• Strong mechanical knowledge with the ability to interpret mechanical blueprints and GD&T (Geometric Dimensioning & Tolerancing).
• Proficiency with calibration procedures for tools such as height gauges, calipers, micrometers, and vision inspection systems.
• Familiarity with quality standards including ISO 13485, ISO 9001, FDA regulations, CGMP, HACCP, and related regulatory frameworks.
• Experience operating coordinate measuring machines (CMM) and vision inspection systems.
• Knowledge of data collection methods and analysis skills for quality metrics.
• Ability to perform precise measurements using calipers, micrometers, height gauges, and other precision instruments.
• Strong understanding of manufacturing processes and quality control procedures.
• Excellent attention to detail with strong organizational skills.
• Effective communication skills to collaborate across departments and document findings clearly.

This position offers an opportunity to contribute significantly to high-quality manufacturing processes within a regulated environment. We welcome candidates committed to excellence in quality assurance and continuous improvement.

#LIFESCI

Pay: $30.00 - $40.00 per hour

Work Location: In person

Salary : $30 - $40