Quality Technician I

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 is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, and quality systems.

Key Responsibilities:

• Under Quality Engineer (QE) oversight, assist with qualification and validation (IQ, OQ, PQ).
• Compile and analyze statistical data to assess process capabilities and control processes.
• Develop inspection test methods and draft inspection procedures with QE oversight.
• Handle Calibration Management including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required.
• Handle Environmental Monitoring Management including collecting samples, testing, entering, and trending results and out of tolerance reporting as required.
• Support the nonconforming material reporting process including verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product.
• Review and approve inspection and device history records as required.
• Support CAPA process by assisting in the investigation and implementation of corrective action.
• Identify areas of improvement and participate in continuous improvement projects.
• Perform Gemba walks and participate in 5S activities.
• Support QEs.
• Complies with company, quality, and safety standards, policies, and procedures.
• Other duties as assigned.

Must Have:

• High School diploma.
• 1 year of experience in manufacturing environment (preferred requirement - Medical Device industry).
• Knowledge of medical device regulations (21CFR820, ISO 13485).
• Technical training and/or experience in related field.
• Working knowledge of basic inspection processes and measurement practices.
• Must be able to read, write and speak fluid English.
• Ability to read and interpret assembly drawings and specifications.
• High proficiency in use of computer systems using standard business software: Outlook, Word, PowerPoint, Excel, MRP/ERP systems.
• Strong verbal and written communication skills.
• Ability to work with a wide variety of functional areas including but not limited to Program Management, R&D, Manufacturing and QA as required.
• Excellent organization and time management skills with an ability to think proactively and prioritize work.
• Flexible and able to accommodate changing priorities and directions.

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.