Engineer II, Design Quality (Hybrid - San Clemente, CA)

Qualifications

• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field required.
• Minimum of two years of experience in R&D and/or Quality required.
• ASQ CQE certification preferred or ability to obtain within one year.
• Knowledge of Quality Management Systems and risk management integration.
• Familiarity with medical device standards, particularly ISO 13485 and ISO 14971.

Responsibilities

• Utilize quality tools and processes to assure product quality.
• Ensure compliance with FDA and international regulatory standards.
• Verify that all quality attributes for design changes are met.
• Participate in design reviews and cross-functional teams.
• Evaluate and mitigate product and process risks to enhance quality.
• Support internal and external audits and inspections.
• Interact effectively with cross-functional team members.

Benefits

• Professional development opportunities.
• Collaborative work environment.
• Exposure to diverse projects in medical device quality assurance.
• Potential for career advancement within the company.