Quality Assurance Leader, ISO 17025 Lab

Element Materials Technology; Warren (MI); On-site; USD 85,000 - 120,000; Full time

Job summary

Element Materials Technology in Warren, MI seeks a Quality Manager to lead the site’s quality program, maintain ISO/IEC 17025 compliance, and drive continuous improvement within the lab. The role reports to the BU Quality Director and collaborates with location leadership to safeguard accuracy and integrity of inspection and testing services.

You will manage accreditation activities, oversee the eQMS, and train staff while maintaining strong customer and regulator relationships.

Qualifications

• Bachelor's degree preferred or equivalent qualification and required experience
• Minimum 5-7 years of work experience in an ISO quality environment
• Experience in ISO/IEC 17025 environment is a prerequisite
• Experience with A2LA, ISO 17025, and quality system rules and regulations
• Strong organizational and time management skills
• Excellent communication skills at all levels of the organization
• Experience in quality investigations, root cause analysis and corrective actions
• Quality management system (eQMS) experience including SOPs/policies and document control

Responsibilities

• Lead maintenance and scope extension of accreditations (e.g., ISO/IEC 17025) and regulatory requirements
• Implement and maintain the QMS with controls for inspection and testing
• Manage day-to-day QMS implementation and support colleagues
• Prioritize activities to meet business and customer needs
• Embed a culture of quality assurance and improvement across laboratory operations
• Ensure customer expectations are met through effective QA/QC and communication with customers/ accreditation bodies
• Maintain accreditations and extend them to service customers and competitive position
• Manage A2LA and other assessments and visits as required
• Respond to findings from assessments per established quality requirements and timelines
• Establish QA/QC programs to reduce cost of poor quality and ensure regulatory compliance
• Provide training on the electronic quality management system (eQMS) across the facility
• Drive and monitor eQMS implementation and usage
• Provide quality training during onboarding and refreshers
• Implement method audits, system audits, and proficiency testing as scheduled
• Manage calibration program and ensure it meets facility requirements
• Compile monthly KPI such as FTR, customer complaints and NCRs
• Maintain relationships with operational colleagues and the broader quality community

Job description

Element Materials Technology in Warren, MI seeks a Quality Manager to lead the site’s quality program, maintain ISO/IEC 17025 compliance, and drive continuous improvement within the lab. The role reports to the BU Quality Director and collaborates with location leadership to safeguard accuracy and integrity of inspection and testing services.

You will manage accreditation activities, oversee the eQMS, and train staff while maintaining strong customer and regulator relationships.