Quality Lab Technician II

Medical Murray; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Medical Murray in North Barrington, IL is seeking a Quality Lab Technician II to support the Quality Department in delivering products that meet quality, quantity, and timeliness standards. The role involves performing advanced product testing using CMM and 4K microscopes, developing CMM programs, and supporting R&D and manufacturing projects through validation phases.

Strong QA experience and documentation skills are essential.

Qualifications

• Experience with quality management systems (QMS) is required.
• Strong knowledge of ISO 13485 and FDA quality systems.
• Bachelor's degree in engineering or equivalent.

Responsibilities

• Follow all aspects of the Quality Management System (QMS), including SOPs.
• Conduct testing and inspection activities to support production, R&D, and quality initiatives.
• Develop and operate CMM programs to execute precision measurement and testing projects.
• Perform detailed lab testing in support of R&D Engineering, Manufacturing Engineering, and the Quality Lab.
• Complete data sheets and documentation accurately in GDP.
• Maintain and support inspection records and metrology data.
• Support calibration activities for gauges and test equipment.
• Participate in validation and qualification studies with production teams.
• Provide training to employees on quality standards, testing methods, and procedures.
• Analyze nonconforming product or process conditions to determine root causes and CAPAs.

Skills

QMS experience

ISO 13485 / FDA quality systems

CMM programming

Statistical methods SPC/DOE

Analytical & problem solving

Education

Bachelor’s degree in Engineering

Tools

CMM software

Job description

Position Title:

Quality Lab Technician II

Location:

North Barrington, IL

The Quality Lab Technician II plays a key role in the Quality Department, supporting departmental objectives to deliver goods and services that meet customer requirements for quality, quantity, and timeliness. This position is responsible for performing advanced product testing utilizing sophisticated 3-dimensional coordinate measuring machines (CMM) and 4K ultra-high accuracy microscopes, supporting quality lab testing initiatives, and contributing to R&D and manufacturing projects as they progress through development and validation phases. The role requires a combination of technical expertise, analytical thinking, and a strong commitment to quality systems and standards.

Key Responsibilities

• Follow all aspects of the Quality Management System (QMS), including applicable SOPs listed in the Training Matrix.
• Conduct testing and inspection activities to support production, R&D, and quality initiatives.
• Develop and operate CMM programs to execute precision measurement and testing projects.
• Perform detailed lab testing in support of R&D Engineering, Manufacturing Engineering, and the Quality Lab.
• Complete data sheets and documentation accurately in compliance with Good Documentation Practices (GDP).
• Maintain and support inspection records and metrology data in coordination with the Equipment Coordinator.
• Support calibration activities for gauges and test equipment.
• Participate in validation and qualification studies in partnership with production teams.
• Provide training to employees on quality standards, testing methods, and procedures.
• Analyze nonconforming product or process conditions to determine root causes, facilitate corrective/preventive actions, and document findings.
• Evaluate nonconformance trends and communicate key issues to process owners and management.
• Perform measurement system analysis (MSA) including repeatability, reproducibility, and process capability studies.
• Utilize various inspection, measurement, and test equipment to ensure product conformance and performance.

Qualifications

• Experience with Quality Management Systems (QMS) is required.
• Strong understanding of ISO and FDA Quality Systems.

Education

• Bachelor’s degree in an Engineering discipline or equivalent combination of education and experience.

Experience

• 2–5 years of experience in Quality Engineering or Quality Lab roles within a medical device environment.
• Experience with ISO 13485, ISO 17025, and FDA 21 CFR Part 820 requirements.
• Experience using or programming coordinate measuring machines (CMM) preferred.
• Computer programming experience a plus.
• Familiarity with FDA and international product standards for catheters and disposable medical devices is preferred.

Skills, Knowledge, and Abilities

• Solid technical knowledge of disposable medical device testing, protocols, and analytical methods.
• Strong understanding of statistical methods such as SPC and design of experiments (DOE).
• Proficient in Microsoft Office and related software applications.
• Excellent analytical, problem-solving, and decision-making abilities.
• Effective verbal and written communication skills.
• High attention to detail and commitment to product and process quality.

Why Join Us

This is an excellent opportunity to contribute to an organization that values precision, innovation, and continuous improvement. The ideal candidate will thrive in a collaborative environment where quality and integrity are at the forefront of everything we do.

Medical Murray is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees