What are the responsibilities and job description for the Senior Design Quality Assurance Engineer #2321 position at Enhanced Compliance Inc.?
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the role
As a Sr. 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.
- 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
- Bachelor’s Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is preferred
- Minimum of 10 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
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.