Position SummaryThe Senior Manager, Quality Assurance is responsible for leading the organization's quality strategy, quality management systems, regulatory compliance framework, and continuous improvement initiatives across multiple functions or business areas. This role provides strategic and operational leadership to ensure products, processes, and systems consistently meet customer expectations, regulatory requirements, and company quality standards.
The role serves as a key business partner to Manufacturing, Engineering, Operations, Supply Chain, and executive leadership to drive operational excellence, risk mitigation, quality performance, ISO compliance, and a culture of accountability and continuous improvement throughout the organization.
Key Responsibilities- Lead the maintenance and continuous improvement of the Quality Management System (QMS), ensuring compliance with ISO 9001 and applicable regulatory requirements.
- Plan, lead, and support internal, external, customer, and certification audits, ensuring audit readiness and timely closure of findings.
- Develop and implement Product Quality Engineering strategies aligned with business objectives and customer requirements.
- Establish and monitor quality metrics, analyze trends, and drive actions to improve product quality and reliability, customer satisfaction, and operational performance.
- Drive robust problem-solving processes using CAPA, 8D, Root Cause Analysis (RCA), FMEA, and other quality methodologies to resolve customer, supplier, manufacturing, and field quality issues.
- Monitor trends and lead investigations of nonconforming materials, customer complaints, warranty claims, and process deviations, ensuring effective corrective and preventive actions.
- Lead quality engineering activities across the product lifecycle, including design transfer, manufacturing support, process validation, and product quality improvement.
- Reduce Cost of Poor Quality (COPQ) through defect prevention, process capability improvement, and continuous improvement initiatives.
- Serve as the primary quality interface for customers, managing quality escalations, complaint resolution, SCARs, and customer audits.
- Lead and mentor quality engineers, fostering a culture of accountability, continuous improvement, and quality excellence.
- Collaborate with Engineering, Manufacturing, Supply Chain, and Operations teams to ensure product and process quality requirements are effectively implemented and sustained.
- Ensure the QMS is scalable, standardized, and effectively deployed across all North American sites to achieve consistent compliance and operational excellence.
- Supporting cross-site quality initiatives and harmonization efforts as our regional footprint continues to grow.
alifications- Bachelor's degree in Engineering, Quality, Manufacturing, or related technical field required. Advanced degree (Master's or Ph.D.) in a related technical field is a plus.
- 10+ years of progressive quality leadership experience in a manufacturing, engineering, or regulated environment.
- 5+ years of leadership experience managing quality teams, systems, and cross-functional initiatives.
- Strong expertise in ISO quality systems, audit management, root cause analysis, CAPA, and continuous improvement methodologies.
- Proven experience in global and regional QMS initiatives.
- Expertise in ISO 9001 and AS9100 is required. Medical Device Standards: Experience with ISO 13485 or FDA 21 CFR 820 is highly preferred.
- Experience leading customers, registrar, and regulatory audits within ISO-certified environments.
- Strong business acumen with the ability to influence senior leaders and drive organizational change.
- Demonstrated experience leading complex operational and quality initiatives across multiple functions or sites.
- Excellent analytical, problem-solving, organizational, and communication skills.
- Proficiency with ERP/MRP systems, quality management systems, and Microsoft Office applications.
