Design Quality Engineer

Advantage Technical is seeking a Design Quality Engineer to join a collaborative team dedicated to ensuring safety, quality, and compliance in medical device design. This role focuses on design changes, material continuity, regulatory compliance, and improvements for manufacturability and cost reduction.

Shift: 8:00 AM - 4:30 PM | Pay: $55/hr

The Design Quality Engineer will apply design controls to projects, support cross-functional teams, and contribute to the development and verification of safe, high-quality products. This role includes imaging diagnostic catheter design changes and working closely with a team of 5 Design Assurance Engineers within a total team of 20.

Responsibilities

• Lead design change projects from scoping through implementation
• Develop, update, and maintain Design History Files and Design Input/Output documentation
• Maintain risk management files, including Hazard Analysis, Task Analysis, and Design FMEA
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports
• Support resolution of PIRs, CAPAs, and NCEPs
• Apply systematic problem-solving to identify, prioritize, and resolve quality issues
• Maintain compliance with the Quality Policy and documented quality processes
• Demonstrate commitment to patient safety and product quality

Qualifications

• Bachelor's degree in an engineering discipline (Master's preferred)
• 5-7 years experience with BS; 3-5 years with MS
• Experience in design assurance, design quality, or related roles in medical device or regulated industries
• Experience with risk management, regulatory compliance, and quality systems
• Strong problem-solving skills and attention to detail
• Medical device experience preferred
• Must have experience in a regulated environment

Why You'll Love This Job

We offer a comprehensive benefits package designed to support your health, financial goals, and work-life balance. This includes medical, dental, and vision insurance, life insurance, short-term disability coverage, and a 401(k) retirement plan. You'll also enjoy weekly pay every Friday, access to employee discount programs, and opportunities to earn referral bonuses.

Join a team that values quality, compliance, and innovation in medical device development. Apply today and make an impact in patient care!

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

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