Senior Quality Control Inspector
11 days ago
Santa Ana
Job Description A nationally recognized medical diagnostics manufacturer specializing in the research, development, and manufacturing of rapid molecular PCR diagnostic devices is seeking an experienced Senior Quality Control Inspector to support its regulated manufacturing operations in Southern California. This role plays a critical part in ensuring product quality, regulatory compliance, and patient safety within an FDA-regulated, ISO 13485-certified medical device environment. The Sr. QC Inspector will: • Perform incoming, in-process, and final inspections in accordance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and internal quality system requirements., • Execute visual, dimensional, and functional inspections of raw materials, components, subassemblies, and finished medical devices to ensure conformance with approved specifications, drawings, and acceptance criteria., • Utilize a broad range of inspection tools and systems including calipers, micrometers, indicators, pin gauges, CMM, Keyence, and optical inspection systems., • Identify, document, and clearly communicate nonconformances, initiating Non-Conformance Reports (NCRs) in compliance with internal CAPA and deviation procedures., • Support investigations by providing inspection data and contributing to root cause analysis and corrective actions as required., • Maintain accurate, complete, and traceable quality records, including Device History Records (DHRs) and receiving inspection documentation, in Oracle PLM and related quality systems., • Ensure compliance with SOPs, work instructions, GMP requirements, and data integrity principles (ALCOA)., • Support and participate in calibration and preventive maintenance programs for inspection equipment in accordance with regulatory and internal requirements., • Assist with training and mentoring QC personnel on inspection techniques, quality procedures, and regulatory expectations., • Support internal and external FDA, ISO, and customer audits as needed. Required Qualifications • High School Diploma or equivalent required; Associate degree or higher preferred., • Minimum of 5 years of Quality Control inspection experience in an FDA-regulated medical device or pharmaceutical manufacturing environment., • Demonstrated working knowledge of 21 CFR Part 820, ISO 13485, and GMP requirements., • Strong proficiency with dimensional inspection methods and equipment; experience interpreting engineering drawings, GD&T, and specifications preferred., • Proven ability to accurately document, investigate, and communicate quality issues and nonconformances., • Experience training others in inspection methodologies and quality system procedures., • Proficient in Microsoft Office (Excel, Word), manufacturing systems, and QMS software., • Highly detail-oriented, well organized, and capable of working independently with minimal supervision., • Strong interpersonal and written/verbal communication skills.