Overview:
The Quality Assurance (QA) Lead, reporting to the Senior Director of Global Quality and Operations, will manage a team of QA professionals responsible for planning and executing quality-related projects across multiple facilities. This individual will lead initiatives to improve product and process quality, analyze quality metrics (e.g., customer complaints, process non-conformances, capability data), and drive continuous improvement efforts. The ideal candidate will bring a proven track record in building and leading high-performance QA teams, with a strong emphasis on regulatory compliance and customer satisfaction.

Key Responsibilities:

• Lead strategic quality initiatives in alignment with organizational objectives and applicable regulatory standards

• Develop, implement, and oversee quality systems to ensure high product quality and compliance

• Drive best practices for process improvement, root cause analysis, and customer satisfaction

• Serve as the Management System Representative

• Manage and enhance quality management system elements, including document control, CAPA, internal/external audits, training, supplier quality, and change management

• Ensure conformance with applicable quality and regulatory standards (e.g., ISO certifications) across all operational areas

• Develop and monitor quality performance metrics, provide analysis, and present results to senior leadership

• Maintain and administer the corrective/preventive action and non-conformance processes

• Oversee and lead internal audit programs aligned with ISO and regulatory standards

• Guide continuous improvement projects that emphasize product and process enhancements

• Lead, mentor, and coach the QA team to achieve operational and professional excellence

Qualifications:
Education:

• Minimum: Bachelor’s degree in Engineering (e.g., Electrical, Mechanical, Chemical) or a scientific discipline with strong statistical emphasis

• Preferred: Advanced degree

Experience and Skills:

• At least 10 years in Quality Assurance or a related field within a regulated industry

• Minimum of 5 years in a leadership role overseeing a Quality Management System (QMS) in an ISO-certified environment

• Certified Lead Auditor (ISO 9001) required

• Familiarity with ISO 9001 and ISO 17025 standards required

• Strong project management, organizational, analytical, and problem-solving skills

• Experience leading third-party audits and ensuring compliance with regulatory bodies

• Excellent interpersonal and communication skills

• Preferred certifications: Six Sigma (Black or Green Belt), PMP, CAPM, or equivalent