Quality Technician II

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

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 challenges, 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 Engineer (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 QE 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.

Must Have:

• High School diploma or equivalent required; associate degree or technical certification preferred.
• 2+ 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.

Good to have:

• Experience with CAPA, risk analysis, validation, and calibration programs are highly desirable.

Salary Range: $24 to 34/hr depending on skills and experience.

Cirtec Medical Corporation considers 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 of its related companies fully endorse equal opportunity for all. 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 a great 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 career and life stage. 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.