Quality Lab Technician II
About The Position
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.
Requirements
- Experience with Quality Management Systems (QMS) is required.
- Strong understanding of ISO and FDA Quality Systems.
- Bachelor2019s degree in an Engineering discipline or equivalent combination of education and experience.
- 220135 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.
- 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.
Nice To Haves
- Experience using or programming coordinate measuring machines (CMM).
- Computer programming experience.
- Familiarity with FDA and international product standards for catheters and disposable medical devices.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
