Quality Engineer — CAPA & Process Improvement Lead

The Goodkind Co; Round Rock (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Goodkind seeks a Quality Engineer to drive quality system improvements in a regulated manufacturing setting. You will analyze data, perform risk assessments, support validation activities, and investigate root causes across QA, QC, Manufacturing, Engineering, and Operations.

You will lead CAPA and change-control efforts, develop quality metrics, and partner to reduce risk while improving process capability and efficiency. A strong GMP background is required.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related technical field.
• 3+ years of experience in Quality Engineering, Quality Systems, Manufacturing Engineering, or Quality Assurance within a regulated manufacturing environment.
• Strong knowledge of GMP requirements and quality systems.
• Experience with root cause analysis, CAPA, deviations, and change control processes.
• Experience supporting validation activities and risk assessments.
• Strong analytical, problem-solving, and organizational skills.
• Ability to analyze and trend data to identify process improvement opportunities.
• Strong written and verbal communication skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Responsibilities

• Lead and support root cause investigations related to deviations, NCRs, CAPA, and process failures.
• Analyze quality and manufacturing data to identify trends, recurring issues, and opportunities for process improvement.
• Support implementation and effectiveness verification of corrective and preventive actions (CAPA).
• Perform risk assessments related to manufacturing processes, quality events, and process changes.
• Support validation activities, including process validation, equipment qualification, and cleaning validation.
• Partner with Manufacturing, QA, QC, and Engineering teams to improve process capability and operational efficiency.
• Develop and track quality metrics, trend reports, and continuous improvement initiatives.
• Support change control activities by evaluating process and quality impacts.
• Assist with development and improvement of procedures, workflows, and quality system documentation.
• Participate in internal audits, inspection readiness activities, and regulatory support initiatives.
• Support implementation of data-driven process improvements and risk mitigation strategies.

Skills

Root cause analysis

CAPA

Data analysis

Process improvement

Quality systems

Validation

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Chemistry, Life Sciences, or related technical field

Tools

eQMS systems

ERP systems

Manufacturing data systems

Job description

Goodkind seeks a Quality Engineer to drive quality system improvements in a regulated manufacturing setting. You will analyze data, perform risk assessments, support validation activities, and investigate root causes across QA, QC, Manufacturing, Engineering, and Operations.

You will lead CAPA and change-control efforts, develop quality metrics, and partner to reduce risk while improving process capability and efficiency. A strong GMP background is required.