Position | Senior Manager, Quality Systems |
Location: | North Americas |
Reports To: | Senior Director of Quality, Americas |
Dept / Function: | Quality |
FLSA Status: | Exempt |
Position Overview: | The Senior Manager, Quality Systems is responsible for leading the development, execution, and continuous improvement of the Quality Management System (QMS) across North America. This role ensures ISO 9001 compliance, strengthens internal audit programs, and drives process standardization and documentation control to support operational excellence, regulatory adherence, and customer satisfaction. This position plays a key leadership role in managing audit readiness, corrective action processes, and quality risk mitigation, ensuring alignment with global standards and customer expectations. The Senior Manager collaborates cross-functionally to implement best practices, continuous improvement initiatives, and quality training programs that enhance operational efficiency and foster a culture of proactive quality management across all sites. |
Main Responsibilities: | - Quality Management System (QMS) Leadership
- Own the development, implementation, and governance of the ISO 9001-compliant QMS across North America, ensuring alignment with regulatory, customer, and internal requirements.
- Establish and enforce standardized processes to ensure QMS integrity, continuous improvement, and effective change management.
- Audit & Compliance Oversight
- Lead and manage internal audit programs, ensuring effective execution, timely resolution of findings, and adherence to compliance standards.
- Partner with external auditors to maintain ISO 9001 certification and successfully navigate customer and regulatory audits.
- Documentation & Process Standardization
- Oversee documentation control systems, ensuring accuracy, accessibility, and compliance across multiple locations.
- Define and enforce documented best practices, ensuring consistency in process execution across all facilities.
- Corrective & Preventive Action (CAPA) Execution
- Lead root cause analysis and corrective action processes, ensuring timely resolution and sustainable improvements.
- Proactively identify and mitigate quality risks that could impact product integrity, process stability, or customer satisfaction.
- Continuous Improvement & Operational Excellence
- Drive Lean, Six Sigma, and process improvement initiatives to optimize efficiency, reduce waste, and enhance quality performance.
- Establish and monitor key performance metrics (KPIs) to track effectiveness, identify trends, and implement data-driven improvements.
- Training & Development
- Develop and implement quality training programs, increasing organizational understanding and engagement in QMS principles, compliance, and best practices.
- Coach and mentor teams to build a culture of quality ownership at all levels of the organization.
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Key Competencies & Skills | - Quality Leadership & Compliance – Expertise in ISO 9001 and quality management systems, ensuring audit readiness and sustained compliance.
- Process Standardization & Documentation – Proven ability to develop, implement, and enforce standardized quality processes across multiple sites.
- Continuous Improvement & Problem-Solving – Skilled in Lean, Six Sigma, and CAPA methodologies, applying structured root cause analysis (5 Why’s, Fishbone, FMEA) to drive lasting improvements.
- Project & Change Management – Experience leading complex quality initiatives, ensuring seamless execution and sustainable results.
- Collaboration & Influence – Strong ability to align cross-functional teams, drive accountability, and foster a culture of quality excellence.
- Communication & Training – Effective in training, coaching, and influencing teams to enhance quality awareness, compliance, and operational efficiency.
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Qualifications: | - Education & Certifications – Bachelor's degree in Quality Management, Engineering, Business Administration, or a related field (preferred). ISO 9001 Lead Auditor Certification and Lean Six Sigma Green Belt are preferred.
- Quality Management Expertise – Proven experience managing QMS in manufacturing, distribution, or industrial settings, ensuring ISO 9001 compliance and certification maintenance.
- Process & Continuous Improvement – Strong background in documentation control, process standardization, and Lean Six Sigma methodologies (PDCA, CAPA, FMEA).
- Customer & Cross-Functional Quality Support – Hands-on experience resolving customer quality concerns and driving cross-functional collaboration on quality initiatives.
- Technical & Analytical Skills – Proficiency in quality management software, documentation control systems, and Microsoft Office tools with strong project management, problem-solving, and organizational abilities.
- Communication & Leadership – Excellent verbal and written communication skills, with the ability to engage, influence, and train teams at all levels.
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Other: | - Travel: Up to 25% within North America to support audits, training, and process improvement initiatives.
- Location Flexibility: Ability to work across multiple sites and remotely as needed.Top of Form
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