Sr Design Assurance Quality Engineer II

Summary

The Senior Design Assurance Quality Engineer II supports the development and commercialization of medical devices by ensuring product designs meet quality, safety, and regulatory requirements. The role contributes to new product development, risk management, and compliance activities while partnering with global cross‑functional teams. This position ensures adherence to design control processes, supports audits, and drives continuous improvement within the Design Assurance function.

Responsibilities

• Support resource planning, allocation, and monitoring for design assurance activities.

• Mentor team members to ensure timely completion of design assurance deliverables.

• Serve as a core team member on assigned projects, including SPRING and Continence initiatives.

• Address design assurance issues and escalate when necessary.

• Drive continuous improvement efforts within the Design Assurance function.

• Participate in internal and external audits.

• Complete required impact assessments within the change control system.

• Support periodic review and maintenance of design control procedures.

• Conduct gap assessments against new standards and contribute to long‑term strategic planning.

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

• Proficiency in quality systems, design assurance, and regulatory standards such as ISO 13485, FDA 21 CFR, and ISO 14971.

• Ability to work both independently and in cross‑functional teams.

• Knowledge of statistical analysis and experience using tools such as Minitab.

• Proficiency with Microsoft Office Suite.

• Experience supporting audits and managing documentation.

• Strong communication, organizational, and problem‑solving skills.

• Fluency in English required.

Competencies