What are the responsibilities and job description for the Quality Engineering Technician position at Isometric Micro Molding, an NMT Company?
About Us
For over three decades, Isometric has been a leading provider of medical-focused micro molding solutions in the United States. Founded in 1990, our company was acquired by Nissha Medical Technologies (NMT) in March 2024. NMT's expertise in endoscopic device design and development combined with our market-leading micro-molding capabilities is revolutionizing the field of drug delivery and medical devices.
We are committed to meeting the evolving needs of medical devices, enhancing component miniaturization, and improving the maneuverability of small and precision components. This contributes to improved device functionality and better patient outcomes.
Job Description:
We are seeking a Quality Engineering Technician to support our Quality department in ensuring compliance to all customer and regulatory requirements through our Quality Management System (QMS). This role will assist in the improvement and maintenance of the QMS while supporting ISO13485 standards.
Key Responsibilities:
- Coordinate CAPA activities within QMS procedures
- Perform calibration system administration
- Train others to established procedures
- Perform First Article inspections
- Perform Gage R&R studies
- Assist in the development and writing of procedures
- Recommend adjustments to the assembly or production process
- Inspect, test, or measure materials or products being produced
- Measure products with CT scanner, calipers, gauges, micrometers, vision systems, or other measurement equipment
- Discuss inspection results with those responsible for products
- Assist in the improvement and maintenance of the Quality Management System
- Draft new procedures and revise existing ones to conform to what is required by process
- Supports Isometric ISO13485 continuous improvement initiatives
- Other duties as assigned
Requirements:
- Associate's degree in a related technical field, or 2 years of relevant experience required
- Understand print and specification reading processes with GD&T concepts
- Ability to inspect a variety of equipment & methods experience
- Medical molding and validation experience preferred
- Independent initiative required
- Ability to work in a procedure-based system and follow guidelines
- Detail and Quality oriented
- Knowledge of clean room practices preferred
- Solid understanding of ISO13485 or ISO9001 continuous improvement
What We Offer:
- 401(k) program with Company match available after 90 days
- 3 weeks of paid time off, 2 personal days, and 11 paid holidays (10 observed holidays 1 floating holiday of your choice)
- Medical, Dental, and Vision options available the 1st of the month followed by 30 days. Health Savings Account options available including a quarterly company contribution
- Company paid coverages include Employee Life/AD&D & Short-Term Disability
- Voluntary benefit options include Long-Term Disability, Supplemental Life/AD&D for Employees, Spouse, and Children, Group Accident Insurance, Home Warranty coverage, Legal support coverage, and Pet insurance