Quality Engineer:
On-siteRound Rock, Texas, United States
Job Summary
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) and perform risk assessments related to manufacturing processes, quality events, and process changes. 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 validation activities, including process validation, equipment qualification, and cleaning validation. Participate in internal audits, inspection readiness activities, and regulatory support initiatives. Assist with development and improvement of procedures, workflows, and quality system documentation.
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
Desired Qualifications
- Experience in OTC, pharmaceutical, cosmetic, or personal care manufacturing
- Experience with validation protocols and equipment qualification activities
- Familiarity with eQMS systems, ERP systems, and manufacturing data systems
- Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies
- Experience supporting audits and regulatory inspections
- Understanding of data integrity principles and risk management tools (FMEA, 5 Whys, Fishbone Analysis)
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