Quality Engineer

Job Description

Quality Engineer (Medical Devices)

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About the role

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IntePros is hiring a Quality Engineer for a leading medical device manufacturer in Mahwah, NJ. You’ll provide hands-on quality engineering support across operations, and help make sure products are free of defects, work as designed, and meet regulatory standards. You’ll develop and implement methods for process control, process improvement, testing and inspection. You’ll also be the voice of Quality across functions, leading projects that improve quality performance and keep the business compliant. This is an individual contributor role for someone who uses sound judgment and works independently with minimal supervision.

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What you’ll do

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• Develop, execute and approve First Article Inspection (FAI) strategies
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• Support the Production Part Approval Process (PPAP)
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• Manage change control processes and change impact assessments
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• Perform equipment and process validations
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• Update and review SOPs and risk management documentation
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• Lead quality initiatives and partner with teams across multiple sites
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What you bring

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• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or a related field
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• 2+ years of industry experience
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• Knowledge of change management and Quality Management Systems (QMS)
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• Strong grasp of engineering and quality concepts
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• Problem-solving and analytical skills, with close attention to detail
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• Excellent written and verbal communication skills, with the ability to build trust with stakeholders
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• Proficiency in Microsoft Word, Excel and PowerPoint
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• A self-starter who handles multiple priorities in a fast-paced environment
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Nice to have

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• Medical device industry experience
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• Familiarity with ISO 13485, EU regulations, and Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
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• Knowledge of risk-based and statistical methods
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