Design Quality Engineer - Medical Device #7324

About the role

As a Design Quality Assurance Engineer, you will ensure that all requirements are met for the Product Lifecycle Process, Risk Management, Design Controls, and Usability Testing. You will work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.

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
• 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 preferred

Qualifications

• 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
• 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

Skills

• Regulatory knowledge in medical device (Class II and III medical devices)
• Writing/reviewing design control documents and compilation of DHFs
• Minitab Statistical software

Benefits

• ECI is an equal opportunity employer

Pay

• TBD

Schedule

• TBD