ECI ยท 22 hours ago
Design Quality Engineer #4895
Marlborough, MA
Full-time
Onsite
Senior Level
5+ years expECI is a global leader in professional consulting services for the life sciences industry, seeking a Design Quality Assurance Engineer. This role involves ensuring compliance with the Product Lifecycle Process and supporting quality-engineering methodologies while working in cross-functional teams.
BiotechnologyConsultingLife ScienceProject Management
No H1B
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
Qualification
Required
Bachelor's Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is required
Minimum of 5 years direct experience in medical device industry
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
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
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