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Manufacturing
Quality Control Systems Manager
Saint Charles, MO

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Confidential

Quality Director

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Job Description

Quality Manager — Confidential Opportunity The Quality Manager leads the quality function for a precision manufacturer serving pharmaceutical, nutraceutical, and other tablet manufacturers worldwide. This position develops and maintains the quality management system that ensures every punch, die, and component meets customer specifications and industry standards; leads the quality department; manages corrective and preventive actions, inspection, calibration, supplier quality, and audits; and partners with engineering and manufacturing to reduce nonconforming product and uphold the company's commitment to the highest quality products and exceptional customer service.
Job Specification:
Essential Duties and Responsibilities Develop, maintain, and control the quality manual, procedures, work instructions, inspection plans, and records that make up the company's quality management system. Lead the day-to-day activities of the quality department, including incoming, in-process, and final inspection; establish priorities and provide direction, coaching, and training to quality personnel. Ensure punches, dies, press components, and refurbished tooling conform to customer drawings, tablet specifications, and applicable TSM and EU tooling standards before shipment. Oversee incoming steel and material verification, including quarantine, hardness and chemical composition testing, and material certifications, and maintain traceability through heat treatment and coating. Evaluate and monitor suppliers of steel, carbide, heat treatment, coatings, and other outside services; maintain the approved supplier list and drive supplier corrective actions. Address customer quality concerns and returned tooling, investigate complaints, communicate findings, and coordinate timely corrective measures with sales, customer service, and engineering. Champion the corrective and preventive action (CAPA) system and lead cross-functional root cause investigations; assign actions, track completion, and verify effectiveness. Plan and lead internal audits and host customer and third-party audits, including supplier audits by pharmaceutical and nutraceutical customers; coordinate responses and ensure follow-up actions are completed. Establish and maintain a calibration system for gauges, micrometers, optical comparators, CMMs, hardness testers, and other measuring equipment, including schedules, records, and out-of-tolerance follow-up. Oversee the identification, segregation, documentation, and disposition of nonconforming product. Partner with engineering and manufacturing to document, review, and improve machining, grinding, heat treat, polishing, and coating processes, inspection methods, and quality controls. Monitor quality metrics (scrap, rework, returns, CAPA status), identify trends, and report results to management. Identify training needs and coordinate instruction in measurement, blueprint reading, and quality awareness. This list is not intended to be all-inclusive. Employees may perform other related duties as assigned. Qualifications and Requirements Must be at least 18 years of age. Bachelor's degree in engineering, quality, manufacturing technology, or a related field, or equivalent experience. Minimum of three years of experience managing a quality department, including experience in a similar role in a tool and die or precision machining manufacturing plant. Ability to read and interpret blueprints, technical drawings, GD&T, and product specifications. Proficiency with precision inspection equipment such as micrometers, optical comparators, CMMs, and hardness testers. Knowledge of quality documentation, inspection practices, statistical process control, root cause analysis, and corrective and preventive action processes. Ability to lead personnel, manage priorities, and follow through on quality issues and improvement activities. Ability to communicate effectively with customers, auditors, suppliers, management, and employees at all levels. Strong analytical, organizational, and problem-solving skills, with attention to detail. Proficiency with Microsoft Office and experience working in an ERP or manufacturing system. Preferred Qualifications Experience developing and implementing an
ISO 9001
quality management system and leading certification audits. ASQ certification such as Certified Manager of Quality/Organizational Excellence (CMQ/OE), CQE, or CQA. Experience supplying components to pharmaceutical, nutraceutical, medical device, or other FDA-regulated customers, including familiarity with cGMP expectations and customer supplier audits. Knowledge of tablet compression tooling, tablet press operation, or TSM and EU tooling standards. Knowledge of tool steels, carbide, heat treatment, and surface coatings, including hardness and material testing. Experience using quality management software. Experience establishing or managing calibration programs and leading quality audits. Lean manufacturing or Six Sigma training (Green Belt or higher). Physical Requirements and Work Environment Office duties require sitting at a desk and using a computer, with periods of standing and walking during shifts of eight or more hours. Manufacturing duties require walking, standing, bending, kneeling, stooping, and reaching in various capacities throughout the day. Inspection duties require close visual examination of small, precision-machined features, with or without magnification. Work is performed in office, inspection, and manufacturing settings with exposure to machine noise, cutting fluids, and moving equipment, and requires following site safety procedures and using required personal protective equipment.
Pay:
$95,800.00 - $116,000.00 per year
Benefits:
401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance
Work Location:
In person

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Health Insurance
  • Dental Insurance