Senior Design Quality Engineer

Provide quality support to design and development teams.

Review and approve design control documents (DHF, DMR, Risk Management File).

Ensure compliance with ISO 13485, ISO 14971, and applicable regulatory standards.

Participate in design reviews and risk assessments.

Support verification, validation, and design transfer activities.

Drive continuous improvement in design quality processes.

Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, and Post-Market).

Bachelor’s degree in Mechanical Engineering or related field.

7+ years’ experience in Design/Development Quality in the medical device industry.

Strong understanding of ISO 13485, ISO 14971, EU MDR, and FDA QSR.

Experience in DHF review, risk management, and design control compliance.

Excellent analytical, problem-solving, and communication skills.