Quality Engineer: Data-Driven Change & Compliance

CORMETECH; Durham (NC); On-site; USD 55,000 - 80,000; Full time

Job summary

CORMETECH, Inc. in Durham, NC, is seeking a quality professional to support the quality management system and continuous improvement efforts. You will analyze quality data, assist audits, and track CAPA actions to ensure product and process compliance with ISO 9001 requirements.

You will collaborate with Operations, Engineering, Laboratory, EHS, and Supply Chain to resolve quality issues, maintain accurate records, and ensure timely closure of actions while upholding internal standards.

Qualifications

• Bachelor's degree in Engineering, Mathematics, Science, or related technical field.
• 0-2 years in quality, manufacturing, or a related environment; internships or co-ops acceptable.
• Basic understanding of quality systems, document control, root cause analysis, and continuous improvement.
• Proficiency in Microsoft Excel; familiarity with data-analysis tools is preferred.
• Strong attention to detail, organization, communication, and follow-through.
• Ability to work with guidance while developing independent judgment and problem-solving skills.

Responsibilities

• Support continuous improvement using basic Lean, problem-solving, and quality tools.
• Collect, analyze, and trend quality data to support risk-based decisions and verify results.
• Support internal audits, including preparation, evidence collection, finding documentation, and follow-up.
• Track CAPA commitments, due dates, implementation, and effectiveness to support timely closure.
• Maintain accurate quality records and support conformity with ISO 9001 and applicable internal requirements.
• Partner with Operations, Engineering, Laboratory, EHS, Supply Chain, and other functions to resolve quality issues.
• Provide clear, timely status updates, escalating risks, and documenting outcomes.
• Coordinate change requests from initiation through closure using the approved change-control process.
• Confirm the change scope, owner, rationale, risk, affected documents, training, validation, and approvals are defined.
• Monitor implementation actions and verify changes are completed as approved before closure.
• Assess effectiveness using objective evidence and identify unintended consequences or repeat issues.
• Maintain traceable records and communicate status, overdue actions, and emerging risks to stakeholders.
• Promote controlled execution: no undocumented, unapproved, or inadequately communicated changes.

Skills

Lean principles

Problem-solving

Quality tools

Attention to detail

Communication

Organizational skills

Education

Bachelor's degree in Engineering, Mathematics, Science, or related technical field

Tools

Microsoft Excel

Data-analysis tools

Job description

CORMETECH, Inc. in Durham, NC, is seeking a quality professional to support the quality management system and continuous improvement efforts. You will analyze quality data, assist audits, and track CAPA actions to ensure product and process compliance with ISO 9001 requirements.

You will collaborate with Operations, Engineering, Laboratory, EHS, and Supply Chain to resolve quality issues, maintain accurate records, and ensure timely closure of actions while upholding internal standards.