Quality Inspector -(NovelCath)

Description

About us:

NovelCath a Cirtec company specializes in the design and development of complex, minimally invasive, interventional medical technologies. We have delivered first-of-a-kind medical devices for the Interventional Cardiology, Structural Heart, Electrophysiology and Neuromodulation markets.

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:

Shift Hours:10:00AM to 6:30PM, Monday to Friday

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records, and equipment calibration.

Key Responsibilities:

• Inspect measure and/or test incoming parts, accessories, assemblies, production first piece, in-process, and final product for conformance to specifications, record results and notify appropriate personnel
• Uses drop indicators, calipers, micrometers, profilometers, multimeters, pin gages, thread gages, thread rings, and other measurement and evaluation-capable equipment for the purposes of assessing conformity to specifications
• Accurately documents and clearly records the results of inspections and testing
• Indicate inspection status of parts with assigned labels and stamps.
• Maintain product identification and traceability.
• Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action
• Presents and/or communicates the status of materials at any time to the Supervisor/Manager
• Communicates the status of materials to engineering
• Protect product during handling and storage in the performance of work.
• Monitor factory environmental conditions, record data and alert adverse conditions.
• Assist with distribution and control of process documentation and quality records.
• Assist with control of measuring and test equipment calibration.
• Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
• Assist with statistical methods of verifying and controlling process capability.
• Provide input when required to quality planning for specific projects and products.
• Provide leadership to production personnel on quality issues.
• Comply with and reinforce the requirements of the Cirtec Quality Management System processes and procedures, ISO 13485 standard, FDA Quality System Regulations, and other customer requirements.
• Follow Occupational Safety and Health regulations, including laser safety practices.

Must Have:

• High School Diploma or GED equivalent
• Minimum of 1 year medical device experience
• Working knowledge of technical drawings, blueprints, specifications, illustrations, and geometric tolerances
• Proficient in the use of microscopes, measuring and test equipment
• Must be able to read, write and comprehend English

Good to have:

• 2 years' experience as a Quality Control Inspector in a regulated industry

Shift Hours:10:00AM to 6:30PM, Monday to Friday

Salary Range: $19 - $22/hour, based on experience and qualifications

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.