Quality Systems Lead - Audits, CAPA & Compliance

TSI Incorporated; Shoreview (MN); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Professional development opportunities

Job summary

TSI Incorporated is seeking a Quality Systems Supervisor to lead the administration and continual improvement of the QMS and calibration program. You will supervise Quality Assurance Inspectors and Calibration Technicians, coordinate CAPA activities, and partner with cross-functional teams to uphold quality standards.

The role emphasizes auditing, training, and performance management, with a focus on ISO 9001/17025 compliance and continuous improvement across manufacturing operations.

Qualifications

• Bachelor's degree in quality, engineering, science, business, or a related field.
• Minimum of 5 years' experience in quality systems, quality assurance, regulatory compliance, calibration, or related quality functions.
• Minimum of 1 year of supervisory, team leadership, or project leadership experience.
• Experience supporting or leading Quality Management Systems, audit programs, and corrective action processes.
• Experience working in a manufacturing, technical, or regulated environment.
• Lead Auditor Certification (ASQ, Exemplar Global, or equivalent) is desirable.
• Experience coordinating quality activities across multiple sites or international operations is desirable.
• Experience leading continuous improvement initiatives and cross-functional projects is desirable.

Responsibilities

• Lead the administration, maintenance, and continual improvement of TSI's Quality Management System (QMS), ensuring compliance with applicable quality standards (e.g., ISO 9001, ISO 17025), customer requirements, and regulatory expectations.
• Lead and manage internal and external quality audits, including customer, certification, and regulatory audits, and serve as the primary quality systems representative during audit activities.
• Own the CAPA process, including investigation support, corrective action implementation, documentation, effectiveness verification, and closure management.
• Plan, coordinate, and facilitate Management Review activities.
• Maintain quality system procedures and forms, and support implementation of quality system improvements across the organization.
• Supervise, coach, and develop Quality Assurance Inspectors and Calibration Technicians, including assigning work, establishing priorities, providing training, supporting employee development, and managing performance.
• Oversee the MTE calibration program, including calibration scheduling, record maintenance, vendor coordination, and compliance monitoring.
• Provide oversight and support for inspection activities, including receiving inspection, quality audits, inspection records, and compliance with established quality requirements and procedures.
• Monitor changes to applicable quality standards, regulatory requirements, and industry best practices; communicate impacts and ensure required updates are implemented across quality system and calibration processes.
• Partner with Manufacturing, Engineering, Operations, Supply Chain, and other functions to resolve quality issues, support compliance initiatives, and drive process improvement efforts that enhance operational effectiveness and customer satisfaction.
• Develop and deliver quality and compliance training, promote awareness of quality system requirements, and foster a culture of continual improvement throughout the organization.
• Establish, monitor, and communicate quality system and calibration metrics, providing recommendations regarding compliance risks, performance trends, and improvement opportunities.
• Coordinate and track training records related to the QMS.

Skills

Leadership

Communication

Organizational skills

Problem-solving

Education

Bachelor's degree in quality, engineering, science, business, or a related field

Tools

Microsoft Office

Job description

TSI Incorporated is seeking a Quality Systems Supervisor to lead the administration and continual improvement of the QMS and calibration program. You will supervise Quality Assurance Inspectors and Calibration Technicians, coordinate CAPA activities, and partner with cross-functional teams to uphold quality standards.

The role emphasizes auditing, training, and performance management, with a focus on ISO 9001/17025 compliance and continuous improvement across manufacturing operations.