Description
Lead the organization’s quality strategy and management system, directing quality assurance and control programs, governance, and continuous improvement across operations, laboratories, and suppliers to ensure compliance, product integrity, and customer satisfaction.
- • Authorize production stops for critical quality or safety issues.
- • Approve contractor and supplier quality plans and agreements.
- • Review quality metrics, statistical studies, technology advances, and evolving regulations; set policy responses.
- • Own and manage the quality organization’s operating and capital budgets.
- • Sponsor evaluation and adoption of new testing and sampling methods and technologies.
- • Oversee selection, validation, and deployment of inspection equipment and quality digital tools.
- • Set sampling policies and review summary analyses to drive data-based decisions.
- • Lead supplier and external laboratory quality audits and resolve systemic gaps.
- • Ensure conformance of materials, in-process goods, and finished products to standards and certifications.
- • Approve quality documentation for regulatory filings, certifications, and inspections.
- • Govern and update the QMS, SOPs, and quality manuals.
- • Publish executive reports on nonconformance, yields, root causes, CAPA, and quality trends.
- • Guide development and approval of product specifications and critical-to-quality attributes.
- • Oversee design transfer and new product introduction readiness; mitigate scale-up risks.
- • Set vendor quality requirements and coach suppliers to close deficiencies.
- • Champion continuous improvement; prioritize and resource corrective and preventive actions.
- • Ensure training and competency for quality and operations staff in QC and analytical practices.
- • Define control plans, critical control points, and risk-based sampling strategies.
- • Approve and maintain validation and test method documentation and acceptance criteria.
- • Direct enterprise defect tracking, dashboards, and quality data governance.
- • Establish inspection and test strategies and acceptance criteria.
- • Align quality requirements with customer needs in collaboration with Sales and Marketing.
- • Communicate quality performance and issues to leadership, plants, and external partners.
- • Review test results and investigations; guide disposition and escalation decisions.
- • Lead and develop a high-performing quality team, including managers, inspectors, and lab staff.
- • Monitor and improve QMS effectiveness, KPIs, audit outcomes, and compliance.
- • Oversee product testing strategy across the product lifecycle.
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
