QA Specialist

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Summary   The QA Specialist is responsible for ensuring product quality, process compliance, and continuous improvement within manufacturing or service delivery operations. This role combines quality control activities (40%), compliance monitoring (30%), documentation management (20%), and process improvement initiatives (10%) to maintain the highest standards of quality and regulatory adherence. The ideal candidate will demonstrate strong analytical skills, meticulous attention to detail, and the ability to collaborate effectively across multiple departments while maintaining rigorous quality standards.

Quality Control & Testing (40%)   Serves as the primary quality resource for assigned production lines or service areas, implementing and maintaining comprehensive quality control programs that ensure products and services meet established specifications and customer requirements.   Inspection & Testing   Conducts in-process inspections and final product inspections according to established sampling plans and quality standards   Performs physical, chemical, and functional testing using calibrated equipment and standardized test methods   Reviews and interprets test results, comparing against specifications to determine accept/reject decisions   Documents inspection findings and test data accurately in quality management systems   Identifies non-conforming materials or products and initiates appropriate containment and disposition actions   Operates and maintains inspection and testing equipment including micrometers, calipers, spectrophotometers, and specialized testing apparatus   Verifies proper calibration status of measurement equipment before use   Quality Monitoring   Monitors production processes to ensure adherence to quality standards and work instructions   Conducts first article inspections for new production runs or process changes   Performs receiving inspections of raw materials, components, and supplies from vendors   Tracks and trends quality metrics including defect rates, first pass yield, and customer complaints   Identifies quality issues in real-time and escalates concerns to production and management teams   Participates in production line trials and validation activities for new products or processes   Conducts periodic audits of workstations to verify compliance with quality procedures   Sampling & Statistical Methods   Implements statistical sampling plans (AQL, ANSI/ASQ Z1.4, etc.) appropriate to risk level   Collects representative samples following established protocols   Applies statistical process control (SPC) techniques to monitor process stability   Creates and maintains control charts to identify trends and out-of-control conditions   Calculates process capability indices (Cp, Cpk ) to assess process performance   Uses statistical software to analyze quality data and generate reports   Compliance & Regulatory (30%)   Ensures quality operations comply with applicable regulatory requirements, industry standards, and customer specifications while maintaining comprehensive documentation of compliance activities.   Regulatory Compliance   Maintains compliance with FDA regulations (21 CFR), ISO standards (ISO 9001, ISO 13485), and other applicable quality system requirements   Supports regulatory inspections and audits by FDA, notified bodies, and customer