Lead Quality Inspector

Job Responsibilities

• Oversight of daily activities in the QC department.
• Preparation of QC Inspection schedule to ensure all manufacturing areas are covered.
• Reporting any non-conformances in a timely manner.
• Supporting NCs and CAPA investigations as required.
• Aiding in product flow between departments.
• Interfacing with Manufacturing department to coordinate inspections of completed product.
• Initiating and/or proposing revisions to standard operating procedures involving new processes or process improvements.
• Training QC Inspectors as required.
• Performing inspections (incoming, in-process, first article, etc.) using various inspection measuring equipment.
• Interpreting and working within guidelines of drawings, specifications, charts, procedures, and other data to determine product or material acceptance.
• Reading and interpreting sampling plans as per the American National Standard Institute (ANSI).
• Overseeing physical and electronic quarantine locations.
• May also perform other related duties, responsibilities, and special projects as assigned.

Desired Minimum Qualifications

• Minimum of 5+ years' experience in Quality Systems / Regulatory Compliance environments, preferably in the medical device, diagnostics, or pharmaceutical industries.
• Familiarity with FDA regulations and ISO series of quality standards preferred.
• Capable of both written and verbal effective communication skills.
• Proficiency in the Microsoft Office suite of products.
• Proficiency in Oracle R12/Agile preferred.