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.