Quality Inspector II

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!

About the role

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.

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 leadership to production personnel in relation to quality.
• Provide Quality Control support to Manufacturing & Engineering.
• Reliable, consistent, and punctual attendance is an essential function of the job.
• Complies with company, quality, and safety standards, policies, and procedures.

Requirements

• High school diploma or General Education Degree (GED) is required.
• 1+ years’ experience in medical device industry and manufacturing required.
• Certificate/s of training related to this field of work (medical or quality assurance).
• 3 years’ experience as a Quality Control Inspector.
• 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.
• Must be able to read, write and speak fluent English.
• 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.

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match

Pay

$20 - $26 hourly, based on experience and qualifications

Schedule

Shift: 5:00am - 3:30pm; Monday-Thursday