Quality Engineer 2 (NCR/CAPA)

Infosoft, Inc.; Draper (UT); On-site; USD 53,689 - 76,466; Part time

Job summary

A leading medical equipment manufacturer is seeking a Quality Engineer 2 to document and manage Non-Conformance Reports (NCRs). The ideal candidate will have 2-4 years of experience and strong attention to detail and technical writing skills. Responsibilities include collaborating with cross-functional teams, ensuring compliance with standards, and preparing management summaries. This is a contract position in Draper, Utah with a focus on quality management systems.

Qualifications

• Strong attention to detail and technical writing skills.
• Familiarity with quality management systems (ISO 13485, FDA QSR).
• Ability to work with cross-functional teams to collect accurate information.

Responsibilities

• Document, track, and manage NCRs for products, processes, or materials.
• Ensure NCRs are clearly written and compliant with standards.
• Collaborate with production, engineering, and supply chain teams.

Skills

Attention to detail

Technical writing

Cross-functional collaboration

NCR software tools

Education

2-4 years of experience

Tools

ISO 13485

FDA QSR

Job description

We are looking for a Quality Engineer 2.

Base pay range

$47.24/hr - $47.24/hr

• Non-Conformance Reporting (NCRs)
• Document, track, and manage NCRs for products, processes, or materials that fail to meet specifications.
• Ensure NCRs are written clearly, accurately, and in compliance with company and regulatory standards.
• Maintain NCR logs and databases for traceability and audits.

Supporting Duties

• Collaborate with production, engineering, and supply chain teams to gather details for NCRs.
• Ensure NCRs include root cause information, corrective/preventive actions, and disposition status.
• Follow up with stakeholders to close NCRs in a timely manner.
• Prepare NCR summaries for management reviews and audits.

Skills & Qualifications

• Strong attention to detail and technical writing skills.
• Familiarity with quality management systems (ISO 13485, FDA QSR, or industry-specific).
• Ability to work with cross-functional teams to collect accurate information.
• Experience with NCR software tools or ERP/QMS systems.

Education/Experience:

• 2-4 years of experience required.

Seniority level

• Associate

Employment type

• Contract

Industries

• Medical Equipment Manufacturing