Description
Plan, direct, and coordinate quality assurance and control activities and resources to ensure manufacturing processes and products meet specifications, regulatory requirements, and customer expectations while optimizing cost and delivery.
- • Direct or coordinate quality assurance and quality control activities across manufacturing operations.
- • Develop QA/QC budgets and approve expenditures for testing, inspection, training, and systems to use resources efficiently.
- • Review production schedules and quality plans to determine inspection points, sampling, staffing, and procedures within time and cost constraints.
- • Review operations and collaborate with engineering and operations to resolve quality issues and process nonconformances.
- • Hire, train, evaluate, and coach quality staff and help resolve personnel issues.
- • Initiate or coordinate programs to reduce defects, scrap, and cost of quality.
- • Prepare and maintain quality metrics, audit reports, CAPA records, and document control logs.
- • Set and monitor product and process standards; oversee incoming, in-process, and final inspection and testing to ensure conformance.
- • Develop, implement, and maintain the quality management system (e.g., ISO 9001), including SPC and production tracking for early issue detection.
- • Collaborate with R&D and process engineering to define specifications, validation plans, and control plans for new products or changes.
- • Coordinate calibration, maintenance, and validation of inspection, measurement, and test equipment.
- • Stay current with quality standards, regulations, materials, and statistical methods; train teams on best practices.
- • Manage supplier quality: qualify suppliers, establish quality agreements, and address supplier nonconformances.
- • Plan and conduct internal audits and supplier audits; ensure corrective actions are implemented and verified.
- • Develop, approve, and enforce SOPs, work instructions, and change control for quality-critical processes.
- • Implement and lead containment, root cause analysis, corrective and preventive actions, and recall or field action processes when needed.
- • Maintain records and certifications to demonstrate compliance with applicable quality, safety, and regulatory requirements.
- • Monitor changes in standards and regulatory requirements and update the QMS accordingly.
- • Analyze quality performance, cost of poor quality, and process capability; drive continuous improvement while meeting compliance.
- • Prepare and present regular quality performance reports and dashboards to leadership and customers.
- • Supervise and develop subordinate QA/QC employees.
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O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
