A Compliance Officer or Analyst monitors internal compliance with company policies and also company compliance with local, state and federal laws. Reviews company documents, including contracts and marketing materials; communicates with employees and develops training and internal policy materials.
Manufacturing / Plastic Injection Molding Position Summary Seeking an experienced ISO Quality Compliance Specialist with hands-on experience maintaining ISO 9001 and
ISO 13485
Quality Management Systems (QMS) in a manufacturing environment. This role combines QMS compliance, audits, documentation, corrective actions, and hands-on quality inspection and measurement. Responsibilities Maintain and support ISO 9001 and
ISO 13485 QMS
documentation and records Coordinate and participate in external, surveillance, and certification audits Manage audit findings and corrective actions through closure Support CAPA, nonconformance, and root-cause analysis processes Maintain document control and quality records Prepare for management reviews and monitor ongoing ISO compliance Review quality and inspection documentation Perform dimensional inspection and verification as needed Operate and/or program CMM equipment Use precision inspection equipment including calipers, micrometers, height gauges, and pin gauges Read and interpret engineering drawings, specifications, tolerances, and inspection requirements Work closely with Production, Quality, Engineering, and Management Qualifications 5-10 years of ISO/QMS and quality experience Direct, hands-on experience with ISO 9001 and
ISO 13485
Experience maintaining and administering a Quality Management System Strong knowledge of CAPA, nonconformances, corrective actions, root-cause analysis, and document control Hands-on CMM experience, including operation and/or programming Strong experience with precision measuring and inspection equipment Ability to read engineering drawings and dimensional tolerances Manufacturing experience required Preferred Experience Plastic injection molding/plastics manufacturing Medical device or medical-product manufacturing Clean-room manufacturing GD&T Developing and maintaining inspection procedures and quality documentation Ideal candidate: A hands-on quality professional who can manage ISO/QMS compliance and audits while also understanding practical inspection, measurement, CMM, and manufacturing processes.
