Senior Design Quality Assurance Manager

Job Title

Senior Design Quality Assurance Manager and Risk Management Expert

About the Role

We are seeking a highly skilled Senior Design Quality Assurance Manager to establish and maintain robust design quality assurance processes and procedures for our Cardiac Surgery business.

Key Responsibilities:

• Develop quality plans for new product development projects, outlining quality objectives, criteria, and methods for design verification and validation.
• Lead risk management activities during relevant product development phases, including risk assessment, mitigation strategies, and risk control measures.
• Oversee design verification and validation activities, including testing, analysis, and reviews.
• Conduct regular design reviews and audits to assess compliance with design controls, quality standards, and regulatory requirements.

Requirements:

• Bachelor's Degree in Engineering or equivalent combination of education and experience.
• Minimum of 10 years of experience in quality assurance or quality engineering roles, with a focus on design quality assurance.
• Proven experience managing others.

Work Environment

We provide hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.