Design Quality Engineer (Medical Device)

Insight Global is looking for a Quality Engineer (Design Assurance) to support the development & prototyping stages of electromechanical medical devices. MUST WORK ONSITE IN NORTH ST. PETERSBURG, FL (TAMPA, FL AREA).

This a long term W2 contract (starting at 9 months+ with intension for continuous extensions as needed). Offering immediate health, dental, and vision enrollment option from day one!

JOB SUMMARY:

The Design Quality Engineer will be focused on design controls and production controls of electro-mechanical medical devices, specifically supporting the development and prototype for an Autoinjector device. Executing quality inspections, ensuring team is keeping up with good documentation practices and supporting the RCA's. Will ensure that product designs meet regulatory, performance, and reliability standards by integrating quality controls into the design process, conducting risk assessments (such as FMEA), and overseeing verification and validation activities.

• Design Assurance & Quality Control: Lead design review activities, ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulations
• Regulatory Compliance : Author and maintain Device Master Records, design controls, risk management documents, and quality protocols; manage change control and validation activities
• Prototyping & Testing : Develop and execute test plans for new and existing products; oversee prototype fabrication, verification, and qualification
• Risk & Problem Solving: Apply FMEA, root cause analysis, and CAPA systems to identify and mitigate risks; track and resolve customer complaint

MINIMUM JOB REQUIREMENTS:

• Committed to a long term W2 contract (starting at 9 months+ with intension for continuous extensions as needed) in North St. Peterburg, FL (Tampa, FL area)
• Bachelor's degree in Engineering field of study
• 5-10+ years experience in related design quality engineering
• Regulated industry experience, medical device highly (class II & III) preferred
• Proficiency in design controls, risk management, validation, and quality tools (FMEA, SPC, CAPA)
• FMEA's experience
• Strong working knowledge of 21 CFR 820
• Strong working knowledge of: ISO 13485, FDA 21 CFR Part 820, ISO 14971 (Risk Management), and GMP requirements