Quality Technician II

About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!

Position Summary

The Quality Technician II is responsible for supporting and executing quality assurance activities across manufacturing and development, with a focus on independently performing complex tasks. This position works closely with Quality Engineers and cross-functional teams to ensure compliance with internal procedures and external regulations. The Technician II serves as a subject matter resource for inspection methods, equipment qualification, and quality systems processes.

Key Responsibilities

• Independently perform and document qualification and validation activities (IQ, OQ, PQ) under Quality Engineering (QE) guidance.
• Lead efforts in statistical analysis and trending to assess process capability and identify areas for improvement.
• Validate, and implement inspection procedures and test methods with limited quality engineering oversight.
• Manage the Calibration and Environmental Monitoring programs, including vendor communication, out-of-tolerance investigation, and trend reporting.
• Review, approve, and troubleshoot nonconforming material reports; assist in determining root cause and driving disposition decisions.
• Lead Device History Record (DHR) reviews and provide quality review training to new staff.
• Support and facilitate CAPA investigations; assist in effectiveness checks.
• Identify and lead continuous improvement initiatives within the quality function.
• Participate in and occasionally lead Gemba walks, 5S, and internal audits.
• Collaborate with cross-functional departments including Manufacturing, R&D, Regulatory, and Engineering.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Minimum Qualifications

• High School diploma or equivalent required; associate degree or technical certification preferred.
• Minimum 2-3 years of quality experience in a manufacturing environment, preferably in the medical device industry.
• In-depth knowledge of 21 CFR Part 820, ISO 13485, and other applicable quality system regulations.
• Demonstrated experience with inspection techniques, statistical analysis tools, and quality documentation systems.
• Proficiency in Microsoft Office and ERP/MRP systems.
• Strong written and verbal communication skills.
• Excellent attention to detail, time management, and organizational skills.
• Ability to independently solve problems, manage tasks, and support multiple priorities in a dynamic environment.
• Experience with CAPA, risk analysis, validation, and calibration programs.

Competitive market salary from $25-33 per hour depending on qualifications and experience.

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.