Quality Engineer

Cormetech Inc•Durham, NC

26d

About The Position

The Quality Engineer supports CORMETECH’s quality management system, process improvement, and compliance activities through data analysis, audit support, CAPA follow-up, and change management and control. The role ensures proposed changes are evaluated, documented, implemented, communicated, and verified without unintended impact on product quality, process performance, customer requirements, or compliance obligations. The position works with Operations, Engineering, Laboratory, EHS, Supply Chain, and other functions to resolve quality issues. It supports continuous improvement, maintains accurate quality records, and helps ensure conformity with ISO 9001 and applicable internal requirements. Success involves timely and traceable change closure, evidence-based effectiveness checks, reliable quality data, timely CAPA and audit follow-up, and early escalation of risks.

Requirements

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

Nice To Haves

Familiarity with data-analysis tools.

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 through 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, escalate risks, and document outcomes.
Coordinate change requests from initiation through closure using the approved change-control process.
Confirm that 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 by preventing undocumented, unapproved, or inadequately communicated changes.