Sr. Quality Inspector - Catheters

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:

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, production first piece, in-process and final product, record results and notify appropriate personnel.
• 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.
• 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 System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
• Follow Occupational Safety and Health regulations, including laser safety practices.
• Other agreed duties within the Quality Department consistent with training, qualification, and experience.
• Provide Quality Support for the disposition of discrepant material.
• Provide Quality Support as needed for product transfers from development to production.
• Provide leadership to production personnel in relation to quality.
• Interact with Quality Engineering to resolve CAPA investigations and in support of Manufacturing.
• Document and issue inspection plans.
• Provide Quality Control support to Manufacturing & Engineering.
• Coordinate and prioritize the daily activities of Quality Control in the absence of the Department Supervisor.
• Monitor inspection results for shifts & trends.
• Reliable, consistent, and punctual attendance is an essential function of the job.

This is not a remote position.

Must Have:

• High school diploma or GED
• 5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility and a regulated environment.
• Certificate/s of training related to this field of work (medical or quality assurance)
• 5 years’ experience as a Quality Control Inspector
• Must be able to read, write and speak fluent English
• Proven experience in inspection and documenting results
• Able to demonstrate competence in interpreting technical drawings & specifications
• Proficient in the use of microscopes, measuring and test equipment
• Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
• Have experience in the use of PC’s and Microsoft Office software applications

Nice to Have:

• Experience in catheter inspections
• Equipment management, such as calibration and preventative maintenance

Salary Range: $24-$32 per hour

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are re