Quality Engineer — Data-Driven Process Improvement

Goodkind Co; Round Rock (TX); On-site; USD 80,000 - 105,000; Full time

Job summary

Goodkind is seeking a Quality Engineer in the Austin area (Round Rock, TX) to drive quality system improvements through data analysis, risk assessment, validation support, and root cause investigation.

You will partner with QA, QC, Manufacturing, Engineering and Operations to improve process capability, support CAPA, validation, audits, and regulatory readiness, strengthening the QMS.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related 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.

Skills

Root cause analysis

CAPA

Data analysis

Process improvement

Validation

Quality systems

Cross-functional collaboration

Education

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

Tools

eQMS

ERP

Job description

Goodkind is seeking a Quality Engineer in the Austin area (Round Rock, TX) to drive quality system improvements through data analysis, risk assessment, validation support, and root cause investigation.

You will partner with QA, QC, Manufacturing, Engineering and Operations to improve process capability, support CAPA, validation, audits, and regulatory readiness, strengthening the QMS.