Job Title: Quality Engineer
Location:
Arlington, Tx
On-Site
Job Summary:
The Quality Engineer (QE) plays a critical role in supporting manufacturing operations and ensuring compliance with internal and external quality standards. This position works cross-functionally to resolve technical issues, support risk management and process improvement initiatives, and drive continuous quality enhancement across the organization. The QE will lead and support quality system activities such as validations, CAPAs, FMEAs, and data analysis, contributing directly to product and process excellence in a regulated environment.
Key Responsibilities:
Quality & Compliance
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Collect, analyze, and present data using statistical tools to support data-driven quality decisions.
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Apply quality tools such as process flowcharting, Pareto analysis, SPC, GR&R, DOE, and hypothesis testing to support process improvements.
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Lead or assist in the execution of QMS deliverables including APQP, risk analysis, complaint handling, and CAPA management.
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Plan and execute process and equipment validations including IQ, OQ, and PQ protocols and reports.
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Conduct Process Capability Studies and support ongoing process capability monitoring.
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Collaborate with cross-functional teams to investigate and resolve production and quality issues.
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Monitor manufacturing processes and products to ensure compliance with FDA (21 CFR 820/210/211), ISO 13485, and company standards.
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Recommend and implement improvements to enhance quality and production efficiency.
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Maintain accurate documentation per QMS procedures, work instructions, and applicable forms.
Other Duties
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Perform additional tasks and responsibilities as assigned by supervisor.
Qualifications:
Required Education and Experience:
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Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
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Minimum of 3 years’ experience in quality assurance within a regulated medical device or pharmaceutical manufacturing environment.
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Working knowledge of FDA regulations and ISO 13485 quality systems.
Required Skills:
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Proficiency in statistical analysis using Excel and Minitab.
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Strong understanding of quality tools: SPC, GR&R, DOE, FMEA, CAPA, and risk analysis.
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Excellent written communication skills for writing protocols, technical reports, and quality documentation.
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Highly analytical and detail-oriented with strong problem-solving capabilities.
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Ability to manage multiple priorities and work independently or collaboratively across teams.
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Skilled in Microsoft Word and Excel for documentation, reporting, and data analysis.
Preferred Qualifications:
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ASQ Certified Quality Engineer (CQE) or equivalent RA/QA certification.
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Experience with ISO 14971 for risk management and process validations.
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Training in Lean Six Sigma or Statistical Process Control (SPC).
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Familiarity with electronic Quality Management Systems (eQMS) such as uniPoint, Arena, or TrackWise.
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Knowledge of cleanroom operations, DI water systems, HVAC, and related medical device manufacturing infrastructure.
No C2C
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