Design Quality Engineer

Title : Design Quality Engineer

Location: Warsaw, IN

Employment Type: Contract W2

About the Role

We are seeking an experienced Design Quality Engineer to support New Product Development (NPD) projects in the medical device industry. This role will focus on design control deliverables, documentation review, regulatory compliance, and risk mitigation while collaborating with R&D, Regulatory, Supply Chain, and Project Management teams.

Key Responsibilities

• Support NPD projects and ensure timely completion of design control deliverables.
• Review design documentation and provide quality and compliance guidance.
• Support design inputs, outputs, design reviews, verification, validation, and design transfer activities.
• Collaborate with R&D, Regulatory, Supply Chain, Project Management, and suppliers.
• Lead documentation review discussions and provide feedback to cross-functional teams.
• Identify compliance gaps and support risk mitigation activities.
• Contribute to quality improvement initiatives; CAPA experience is a plus.

Required Qualifications

• 4+ years of Design Quality Engineering experience.
• Medical device industry experience.
• Strong knowledge of design controls and the product development lifecycle.
• Experience with design inputs, outputs, verification, validation, and design transfer.
• Experience working with suppliers and cross-functional stakeholders.
• Excellent communication, documentation review, and collaboration skills.

Preferred Qualifications

• Experience with CAPA processes and quality investigations.
• Experience supporting NPD projects in a regulated medical device environment.

Salary

The hourly rate for this position is $40-45/hr on W2, depending on experience and qualifications.

Benefits

This is a contract position and does not include employer-provided benefits.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background checks may be conducted in accordance with applicable law.

Applicants must be authorized to work in the United States.