Quality Inspector 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:

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, assist control of process documentation, records, and equipment calibration.

Key Responsibilities:

• Inspect or test incoming parts, accessories, assemblies, production start-up, in-process, and final product for conformance to specifications, record results and notify appropriate personnel.
• Accurate documents and clearly records the results of inspections and testing in accordance with Cirtec GDP policies.
• Indicate inspection status of parts with assigned labels and stamps.
• Maintain product identification and traceability.
• Control non-conforming products in accordance with documented procedures.
• Initiate non-conformance reports if applicable.
• Presents and/or communicates the status of products at any time to the Supervisor/Manager.
• Communicates the status of NPI related products to engineering when requested.
• Protects product during handling and storage in the performance of work.
• Monitors environmental conditions, by performing particle and pressure testing. Recording data and alerting leadership of any 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 if requested.
• Assist with statistical methods of verifying and controlling process capability.
• Provide guidance 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,
• Reliable, consistent, and punctual attendance is an essential function of the job.
• Comply with company, quality, and safety standards, policies, and procedures.
• Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Must Have:

• High school diploma-GED required.
• Certificate/s of training related to this field of work (medical or quality assurance) preferred.
• 2 years' experience as a Quality Control Inspector in a regulated industry preferred
• Proven experience in inspection and documenting results
• Proficient in the use of microscopes, measuring and testing equipment.
• Excellent working knowledge of technical drawings, blueprints, specifications, illustrations, and geometric tolerances
• Must be able to read, write, and speak fluent English.
• Experience in the use of PC's and Microsoft Office software applications

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.