Design assurance engineer

The primary responsibility of the Design Assurance Engineer is to ensure quality assurance in compliance with industry standards. This involves working with the manufacturing team to conduct test method validations and diagnose and resolve any issues in the manufacturing and quality system. The engineer is also responsible for coordinating risk assessment activities and ensuring compliance with FDA regulations.

Roles and Responsibilities:

• Adherence to quality systems and ISO/GMP standards
• Developing and documenting test protocols
• Creating and executing test plans, schedules, and objectives
• Diagnosing and resolving manufacturing and quality system issues
• Writing, analyzing, and reporting process validation protocols
• Coordinating supplier and vendor quality specifications
• Managing risk assessment activities
• Complying with FDA regulations
• Participating in cross-functional teams
• Developing and applying test method validations
• Validating assessments for safety
• Evaluating design input and output
• Reviewing specifications and ensuring compliance with technical standards
• Providing feedback on technical design process and procedures

Experience:

The ideal candidate should have an MS degree and at least 2 years of experience in the medical device industry. They should have a strong understanding of design control and test method validation, as well as FDA regulations and ISO/GMP. Experience in risk management, process verification, and design control is also preferred.

Skills:

Good communication skills are required to effectively delegate tasks to engineers. The candidate should have knowledge of regulatory compliances in the biomedical industry, be able to function independently as well as in a team, and possess data analysis skills.