Quality Systems Lead: Audits, CAPA & Compliance

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

Benefits offered by this job

Health Insurance

401(k) with company match

Paid time off

EAP

Professional development opportunities

Job summary

TSI Incorporated is seeking a Quality Systems Supervisor to steward the QMS and calibration program, supervise QA Inspectors and Calibration Technicians, and drive continuous improvement with cross-functional teams.

The role requires a Bachelor’s degree in a related field and at least five years in quality systems, with experience in audits, CAPA, and regulatory compliance within a manufacturing or technical setting. Competitive benefits and leadership opportunities are offered.

Qualifications

• Bachelor’s degree required.
• Minimum of 5 years’ experience in quality systems, QA, 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.

Responsibilities

• Lead the administration, maintenance, and continual improvement of the QMS, ensuring compliance with 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 audits.
• 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 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 updates are implemented.
• Partner with Manufacturing, Engineering, Operations, Supply Chain, and other functions to resolve quality issues and drive process improvement.
• Develop and deliver quality and compliance training, promote awareness of quality system requirements, and foster a culture of continual improvement.
• Establish, monitor, and communicate quality system and calibration metrics, providing recommendations on risks, trends, and opportunities.
• Coordinate and track training records related to the QMS.

Skills

Quality Management Systems

Auditing

CAPA

Leadership

Cross-functional collaboration

Calibration programs

Regulatory compliance

Documentation

Education

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

Tools

Microsoft Office

QMS software

Job description

TSI Incorporated is seeking a Quality Systems Supervisor to steward the QMS and calibration program, supervise QA Inspectors and Calibration Technicians, and drive continuous improvement with cross-functional teams.

The role requires a Bachelor’s degree in a related field and at least five years in quality systems, with experience in audits, CAPA, and regulatory compliance within a manufacturing or technical setting. Competitive benefits and leadership opportunities are offered.