Design Quality Assurance Engineer - Remote #2062

ECI is a global leader of professional consulting services for the life sciences industry, providing transformative solutions to their clients. The Design Quality Assurance Engineer will ensure compliance with product lifecycle processes and work with cross-functional teams to maintain quality-engineering methodologies.

Responsibilities:

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
• Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards
• Support Usability Engineering and planning documentation
• Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics
• Provide key quality trending information and data
• Offer quality and compliance input for post-market activities such as design changes, supplier auditing, and customer complaint investigations
• Identify, prioritize, communicate, and resolve quality issues
• Lead implementation activities for post-market surveillance, product feedback, and corrective and preventive action programs
• Support internal and external audits

Requirements:

• Bachelor's Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is required
• Minimum of 5 years direct experience in medical device industry (active implantable devices)
• Ability to perform work accurately and thoroughly
• Ability to communicate effectively in written and oral form
• Excellent report writing skills essential along with the ability to find a solution or deal proactively with work related problems
• Ability to develop and sustain positive relationships with internal as well as external customers
• Identifying creative and efficient solutions to engineering challenges
• Translating customer requirements into workable product ideas and solutions
• Good analytical and problem-solving skills
• Broad and in depth regulatory knowledge in medical device (Class II and III medical devices)
• Vast experience in writing/reviewing design control documents and compilation of DHFs
• Experience with Minitab Statistical software