Quality Checker 2nd Shift

The Quality Inspector – Metrology is responsible for performing dimensional and visual inspection of injection-molded medical device components to ensure compliance with customer specifications, engineering drawings, and quality standards. This role requires strong metrology and inspection skills and serves as the first line of defense in identifying nonconformances and preventing defective product from advancing through production or reaching customers. The inspector operates precision measurement equipment, including CMM and vision measurement systems, and must adhere to Good Documentation Practices (GDP) at all times to ensure accuracy, traceability, and compliance with ISO 13485 and FDA requirements. This is a 2nd shift position (3:00 PM to 11:30 PM, Monday through Friday). The Quality Inspector may be assigned other tasks at the direction of the Quality Manager and must be willing to work overtime or alternate shifts as needed to support production and quality requirements.

Essential Duties and Responsibilities:

Perform routine dimensional and visual inspections of molded medical device components on the production floor and in the quality lab.

Use precision metrology equipment (e.g., calipers, micrometers, height gages, pin gauges, go/no-go gauges, optical comparators, vision systems, and CMMs) to verify part conformance to specifications.

Operate advanced measurement systems, including Keyence LM-X Series and IM Series, RAM Sprint CNC, Zeiss Spectrum II (TP20), and Micro-Vu Vertex 26 equipment.

Interpret engineering drawings, GD&T, critical dimensions, and tolerance schemes related to molded components.

Conduct in-process inspections at molding machines to verify part conformity, including visual checks for flash, short shots, splay, contamination, and other molding defects.

Follow standardized inspection plans, control plans, sampling plans, and work instructions designed for medical device manufacturing.

Record inspection results accurately on check sheets, inspection logs, device history records (DHRs), or within electronic quality systems.

Document and segregate nonconforming product, initiating Nonconformance Reports (NCRs) as needed, and support nonconformance documentation with accurate, objective dimensional data.

Ensure traceability and proper labeling of inspected product.

Ensure inspections are performed in alignment with company SOPs, ISO 13485, FDA 21 CFR Part 820, and customer requirements.

Support internal and external audits with inspection data and records.

Assist with routine calibration checks and proper care of metrology instruments.

Support Gage R&R studies and measurement system analysis under guidance from Quality Engineering.

Promote Good Documentation Practices (GDP) and adherence to cleanroom and GMP guidelines.

Maintain proper control of quality records as defined by the Quality Management System.

Maintain an organized, clean, and GMP-compliant work area.

Perform any other duties necessary to support the quality function as assigned by the Quality Manager.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

High school diploma or equivalent required; technical training in Quality, Metrology, or Plastics Manufacturing preferred.

Strong metrology and inspection skills required, including proficiency with common inspection tools (calipers, micrometers, height gages, pin gauges, etc.).

Experience with Keyence LM-X Series, Keyence IM Series, RAM Sprint CNC, Zeiss Spectrum II TP20, and Micro-Vu Vertex 26 equipment preferred.

Experience programming CMM and vision measurement systems is a plus.

Solid knowledge of GD&T (Geometric Dimensioning & Tolerancing) and blueprint reading.

Ability to follow written procedures and maintain documentation discipline in a regulated (ISO 13485 / FDA) environment.

Must be able to read, write, and speak English fluently to ensure accurate documentation and effective communication.

Strong attention to detail, organizational skills, and ability to work independently in a fast-paced environment.

Good communication skills to effectively interface with production and engineering teams.

Basic knowledge of Microsoft Word and Excel; familiarity with Minitab is a plus.

Ability to work the 2nd shift schedule (3:00 PM to 11:30 PM, Monday through Friday), with overtime as needed.

Cinova Medical offers competitive pay

Benefits:

Medical

Dental

Vision

Life

STD

LTD

401(k) with company match

Paid Time Off

This is a 2nd shift position. The hours are 3:00pm-11:30pm Mon-Fri.

Cinova Medical, Inc. is an EOE AA M/F/Vet/Disability Employer and Drug Free Workplace.

Upon hire, Cinova Medical, Inc. uses E-Verify to verify employment eligibility for roles based in the United States.

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