Sr. Quality Engineer

Vale Group has partnered with a company in the medical device manufacturing industry, based in Scottsdale , who is actively searching for an experienced Senior Quality Engineer to work onsite for an opportunity paying 100-140k , based on experience. This role calls for a hands-on professional with a robust background in quality assurance, risk assessment, and regulatory compliance. The ideal candidate will have a strong grasp of ISO and FDA quality frameworks and the ability to lead investigations, audits, and continuous improvement initiatives across both development and production environments.

Benefits of the Senior Quality Engineer include : Excellent career growth opportunity as well as highly competitive benefits.

Requirements of the Senior Quality Engineer :

• ? Minimum 5 years of relevant experience in quality within the medical device industry
• ? Bachelors degree in a scientific or engineering field
• ? Working knowledge of ISO 13485, FDA QMSR, and ISO 14971 standards
• ? Prior audit participation and CAPA / root cause analysis experience
• ? Experience with risk management methods including pFMEA
• ? Background in compliance tools, QMS procedures, and documentation
• ? Proficiency in Microsoft Office suite; experience with document control systems is a plus

Responsibilities of the Senior Quality Engineer :

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