Design Quality Engineer

About the Role

We are looking for a Design Quality Engineer to join our team and play a key role in supporting product development and sustaining engineering activities. This position ensures that design processes meet regulatory requirements and internal standards while enabling innovation and maintaining product integrity. The ideal candidate will collaborate closely with cross-functional teams, including R&D, manufacturing, and regulatory, to drive quality throughout the design lifecycle.

Key Responsibilities

• Design Control Compliance: Support and maintain design control processes in alignment with FDA, ISO 13485, and other applicable regulations.
• Risk Management: Participate in risk analysis activities (e.g., FMEA) to identify and mitigate potential design-related issues.
• Design Change Assessment: Evaluate proposed design changes for impact on product functionality, safety, and compliance.
• Verification & Validation: Assist in planning and reviewing design verification and validation activities to ensure requirements are met.
• Documentation: Prepare and maintain design history files, technical reports, and quality records to support audits and regulatory submissions.
• Cross-Functional Collaboration: Work with engineering, manufacturing, and regulatory teams to resolve design issues and ensure smooth product transitions.
• Continuous Improvement: Contribute to process improvements that enhance design quality and reduce risk across the product lifecycle.

Qualifications

• Bachelor's degree in engineering or a related technical discipline.
• Experience in medical device development or a regulated industry preferred.
• Familiarity with design control principles, risk management, and quality systems.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication skills and ability to work in a collaborative environment.