Quality Inspector I - 2nd shift Mon to Thurs 3pm to 1am

About the role

Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices since 1990. We specialize in design, development, and manufacturing of medical devices across various fields including active implants, neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components. Our teams are dedicated to growth, innovation, and collaboration, always striving to improve our support for clients.

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.
• Accurately document and clearly record 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.
• Maintains environmental conditions by performing particle and pressure testing, recording data, and alerting leadership of any adverse conditions.
• Affixes and maintains process documentation and quality records.
• Assists with the calibration of measuring and test equipment.
• Participates in internal quality audits to verify compliance with documented procedures and specifications, record results, and verify audit corrective action if requested.
• Provides guidance to production personnel on quality issues.
• Complies with and reinforces the requirements of the Cirtec Quality Management System processes and procedures, ISO 13485 standard, FDA Quality System Regulations, and other customer requirements.

Requirements

• 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 test equipment.
• Excellent working knowledge of technical drawings, blueprints, specifications, illustrations, and geometric tolerances.
• Experience in the use of PC’s and Microsoft Office software applications.

Qualifications

• Ability to read, write, and speak fluent English.

Skills

• Quality Control Inspection
• Documentation and Record Keeping
• Environmental Monitoring
• Equipment Calibration
• Internal Audits
• Statistical Methods
• Process Capability Verification
• Communication and Guidance

Benefits

• Training and Career Development
• Healthcare and Well-being Programs
• Paid Time Off
• 401(k) Retirement Savings with a Company Match

Pay

$19.35 - $25.09 / hour

Schedule

N/A

Benefits

• Training and Career Development
• Healthcare and Well-being Programs
• Paid Time Off
• 401(k) Retirement Savings with a Company Match