Quality Sys Engineer II 6117
Quality Engineer – Medical Device Manufacturing
Mainz Brady Group is seeking an experienced Quality Engineer to support manufacturing processes, product quality, and regulatory compliance within a medical device environment. The ideal candidate has strong experience with quality engineering, process validation, ISO/QSR requirements, and continuous improvement.
Responsibilities
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Evaluate manufacturing processes, methods, and equipment to ensure quality and performance standards.
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Develop and implement quality plans for manufacturing equipment, processes, and products.
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Monitor process performance, identify quality issues, and implement corrective actions.
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Ensure compliance with ISO, QSR, and applicable regulatory requirements.
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Partner with suppliers on new product introductions to meet quality and performance standards.
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Support Manufacturing, Sourcing, and Development teams with quality requirements and regulatory compliance.
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Apply statistical analysis, process control, FMEA, and product testing methodologies.
Qualifications
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Bachelor’s degree in Engineering or related field.
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5–7 years of Quality Engineering experience, preferably in medical device manufacturing.
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Strong knowledge of ISO/QSR regulations, FMEA, design assurance, and process capability.
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Experience with GD&T, blueprint reading, CMMs, and optical comparators.
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Knowledge of statistical process control (SPC), quality testing, and manufacturing processes.
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Strong communication, problem-solving, and cross-functional collaboration skills.
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CQE or CRE certification preferred.
