Quality Inspector

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:

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-confirming 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-confirming 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.
• Other agreed duties within the Quality Department consistent with training, qualification, and experience.
• Reliable, consistent, and punctual attendance is an essential function of the job.
• Complies with company, quality, and safety standards, policies, and procedures.
• Other duties as assigned.

Must Have:

• High school diploma-GED required.
• Proven experience in inspection and documenting results.
• Proficient in the use of microscopes, measuring and test equipment.
• Excellent working knowledge of technical drawings, blueprints, specifications, illustrations, and geometric tolerances.
• Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training.
• Must be able to read, write and speak fluent English.
• Experience in the use of PC's and Microsoft Office software applications.

Good to have:

• Certificate(s) of training related to this field of work (medical or quality assurance) preferred.
• 2 years' of experience as a Quality Control Inspector in a regulated industry preferred.

Salary Range: $21.01

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.