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Quality Engineer

The Moog Medical Devices Group designs, manufactures, and distributes advanced infusion systems that improve medication safety, optimize application performance and reduce medical expenses. Our infusion and enteral products are used in both hospital, at home, and in alternate care sites. Our electronic ambulatory infusion devices are complemented with advanced clinical software management tools, satisfying both clinical and operational requirements.

Quality Engineer

This role will have a critical role in fostering overall quality and ensuring compliance with regulatory requirements and international standards with respect to quality system, manufacturing, and medical device design and development.

The Quality Engineer will be responsible for:

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Review and approval of product development lifecycle artifacts

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Compliance with FDA Quality System Regulation and international standards.

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Coaching functional groups in verification and validation of medical device designs and manufacturing processes

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Supporting global cross-functional development and/or maintenance projects

Core Responsibilities:

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Identify compliance gaps and work with Engineering to resolve compliance issues

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Identify improvement opportunities within the company Quality Management System (QMS)

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Support cross-functional projects to improve and maintain compliant, effective and efficient quality processes

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Foster and support a culture of quality throughout the Engineering organization

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Maintain up-to-date knowledge of regulatory requirements, international standards, and company QMS procedures for areas of responsibility

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Complete required training in a timely manner

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Other projects as assigned by management

Education and Experience:

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B.S. degree in Engineering or a closely related discipline from an accredited university

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Product development experience (requirement specification, design, implementation, test)

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QA or engineering/development experience in a regulated industry

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Experience in applying software development lifecycle and quality system principles, including Good Documentation Practices

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Working knowledge of regulatory requirements and international standards such as FDA Quality System Regulation, Medical Device Directive, ISO 13485, ISO 14971, etc.

Preferred Qualifications:

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Quality Assurance/Engineer/Testing certification

Excellent attention to detail and ability to consistently meet high standards of quality

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Good organization and time-management skills, and ability to work simultaneously on multiple projects

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Proficiency using Microsoft Office tools: Word, Excel, PowerPoint and Outlook

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Experience in automated testing techniques and tools

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Understanding of risk management principles and practices

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Experience in collection and analysis of quality metrics

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Working knowledge of statistical methods

MMDG offers a wide range of benefits, including: comprehensive medical and dental insurance at competitive rates, life insurance, short and long term disability insurances, 401(k) plan with a company match, generous paid time off policy for work life balance, and the opportunity to work in a collaborative and innovative team environment.

EOE/AA Minority/Female/Disability/Veteran/Gender Identity/Sexual Orientation

Moog is a performance culture that empowers people to achieve great things. Our people enjoy tackling interesting technical challenges in a culture where everyone trusts each other to do the right thing. For you, working with us can mean deeper job satisfaction, better rewards, and a great quality of life inside and outside of work.

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