Description
Plan, direct, and continuously improve the Quality Management System (QMS), setting policies, controls, and metrics that ensure compliance and consistent product quality across labs, production, and suppliers.
- • Halt production or product release when critical quality or compliance issues arise.
- • Review and approve supplier quality plans and contractor deliverables.
- • Track regulatory changes, standards, and technology trends to keep the QMS current.
- • Develop and manage budgets for quality systems and compliance activities.
- • Assess and implement new testing, sampling, and monitoring methodologies.
- • Select and deploy quality systems tools, eQMS platforms, and inspection equipment.
- • Oversee sampling strategies and analysis of production data for quality trends.
- • Plan and conduct internal audits and supplier audits, including external labs.
- • Ensure controls verify incoming materials, in-process units, and finished goods meet standards.
- • Prepare and review quality documentation for regulatory submissions and inspections.
- • Maintain and periodically update SOPs, work instructions, and the quality manual.
- • Issue reports on nonconformances, CAPA status, root cause analyses, and quality metrics.
- • Ensure quality requirements are defined in product and process specifications.
- • Integrate quality systems and design controls into new product introduction.
- • Train suppliers and contractors on quality requirements and corrective actions.
- • Lead problem-solving to address systemic quality issues and drive continuous improvement.
- • Train employees on QMS procedures, document control, and compliance practices.
- • Define critical control points and sampling plans in procedures.
- • Own document control processes for quality procedures, records, and forms.
- • Oversee tracking of defects, test results, complaints, and other quality data.
- • Approve inspection, testing criteria, and control plans within the QMS.
- • Collaborate with sales and marketing to translate customer requirements into quality controls.
- • Analyze quality data and provide actionable feedback to production and R&D.
- • Lead and develop teams responsible for document control, CAPA, and auditing.
- • Measure and improve QMS effectiveness through KPIs and management review.
- • Ensure validation and calibration programs meet regulatory and company standards.
- • Govern product testing processes to ensure compliance throughout the lifecycle.
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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
