Quality Systems Lead: QMS, CAPA & Audits

美国TSI集团中国公司

Saint Paul (MN)

On-site

USD 90,000 - 105,000

Full time

3 days ago

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Benefits offered by this job

Health Insurance

401(k) Match

Paid Time Off

Job summary

TSI is seeking a Quality Systems Supervisor to maintain and continually improve our Quality Management System (QMS) and calibration program. You will supervise Quality Assurance Inspectors and Calibration Technicians, drive internal and external audits, manage CAPA, and partner with Manufacturing, Engineering, and Operations to enhance compliance and process effectiveness.

The role requires a Bachelor's degree in a related field and at least 5 years in quality functions, plus 1 year in a

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.

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 Corrective and Preventive Action (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 Measurement and Test Equipment (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.