Quality Equipment Technician

Job Description

Job DescriptionQuality Equipment Technician

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Pay Range:$25.00–$30.00 per hour

Location: Roseville, MN

Position Summary

We are seeking a detail-oriented and technically skilledQuality Equipment Technician to support our manufacturing and Research & Development operations. The Quality Equipment Technician is responsible for ensuring that medical device testing, measuring, tooling, and production equipment is properly calibrated, functional, clean, and maintained.

This position plays an important role in maintaining equipment accuracy, supporting regulatory compliance, and ensuring reliable manufacturing and testing processes. The technician will perform preventive maintenance, coordinate external calibration services, and maintain accurate equipment and tooling records in accordance with company procedures and applicable medical device regulations.

The ideal candidate is organized, dependable, technically capable, and comfortable working in a regulated environment where accuracy and documentation are critical.

Key ResponsibilitiesEquipment Calibration & Maintenance

• Ensure testing and measuring equipment, including tools, gauges, and production equipment, is properly calibrated and functioning accurately.
• Perform preventive maintenance and routine inspections of equipment and tooling.
• Identify equipment issues and coordinate appropriate repairs, maintenance, or calibration activities.
• Maintain equipment in a clean, safe, and functional condition.
• Schedule and coordinate external calibration providers and service vendors as needed.
• Monitor calibration and maintenance schedules to ensure activities are completed on time.

Documentation & Compliance

• Maintain accurate and timely equipment calibration, maintenance, and inspection records.
• Document inspection and maintenance outcomes in accordance with established procedures.
• Manage calibration records and equipment information within the electronic Quality Management System (eQMS).
• Prepare and maintain tooling and equipment documentation.
• Support compliance with applicable medical device quality and regulatory requirements, includingISO 13485, FDA regulations, EU MDR, and cGMP.
• Ensure equipment records are complete, accurate, current, and readily available for internal and external audits.
• Escalate equipment concerns, calibration issues, or potential compliance concerns to appropriate personnel.

Cross-Functional Support

• Support manufacturing and Research & Development teams with equipment and tooling needs.
• Communicate equipment status, maintenance requirements, and calibration needs clearly and promptly.
• Coordinate with personnel ranging from manufacturing floor operators to quality and management teams.
• Assist with quality and equipment-related projects as needed.

Essential Skills & Qualifications

• High school diploma or equivalent required.
• Associate degree, technical degree, or relevant technical certification preferred.
• Experience performing preventive maintenance and/or calibration activities in a regulated work environment required;medical device experience preferred.
• Strong attention to detail with excellent organizational, coordination, and time-management skills.
• Ability to accurately maintain equipment, tooling, maintenance, and calibration records.
• Proficient computer skills, includingMicrosoft Word, Excel, and spreadsheets.
• Experience using anelectronic Quality Management System (eQMS) is beneficial.
• Ability to understand and follow written procedures, work instructions, and quality requirements.
• Strong communication skills with the ability to clearly communicate equipment needs and status to diverse teams.
• Ability to prioritize multiple tasks and meet scheduled calibration and maintenance deadlines.
• ISO 17025 testing and calibration certification or related training is highly preferred.

Preferred Experience

• Experience in a medical device, pharmaceutical, laboratory, or other regulated manufacturing environment.
• Familiarity withISO 13485, FDA, EU MDR, cGMP, or ISO 17025 requirements.
• Experience coordinating third-party calibration and service providers.
• Experience working with equipment calibration databases or eQMS platforms.
• Technical experience with measurement tools, gauges, production equipment, and test equipment.

What We’re Looking For

The successful candidate will be someone who takes pride in accuracy, organization, and maintaining high-quality standards. You should be comfortable working independently while also collaborating with manufacturing, quality, and R&D teams. A strong sense of urgency, attention to detail, and commitment to accurate documentation are essential to success in this role.

If you are a technically minded professional who enjoys keeping equipment accurate, reliable, and compliant, we encourage you to apply for the Quality Equipment Technician position.