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FDA Medical Device Quality Engineer (Relocation Package Available)

Company Name:
Eric Lyublinsky
The Position
With a number of development projects, there is a need to recruit qualified candidates with appropriate experience and excellent skills. The main focus of current activities in the group is the development and manufacturing of drug delivery solutions for our customers, the leading pharmaceutical companies. The candidate is expected to be part of a team serving multiple customers. He/she will also contribute ideas/concepts for new products and services. This role requires considerable team work, leadership, and excellent project coordination and prioritization skills.
Key Responsibilities
Serve as GMP champion throughout the design and development process
Identify critical design parameters through risk analysis
Develop test methods and write protocols to characterize design parameters
Oversee technician execution of test protocols, analyze data, and write test report
Oversee and support of verification and validation activities for new product development
Provide domain expertise to product development team in statistical sampling and analysis
Own the Design History File, Design Master Record, and Device History Record for team portfolio

Education, Experience and Qualifications
The candidate must have a degree in manufacturing engineering or mechanical engineering (Bachelors required, advanced degrees a plus).

The candidate should enjoy working in a dynamic company environment with a focus on technical excellence, responsiveness to the customer and innovative thinking.
The candidate's skills will include some, or all, of the following:
3-5 years of experience (Target 7-10 years) as a quality engineer in the development of new medical products
Being part of a small, dedicated, cross-functional development team
Test method development and execution, including experience with metrology, GD&T, and mechanical testing
Experience with mechanical testing instrumentation (e.g. Instron, Zwick)
Knowledge of transfer to manufacturing, manufacturing processes, medical device regulations, FDA submissions, testing, planning
Strong preference for candidates from pharmaceutical and/or medical device industry with experience in the development of combination products
Experience or willingness to work in a multi-skilled environment (possess cross-disciplinary skills or ability to grasp requisite skills outside of core skill-set)
Ability to make independent decisions and successful track record of influencing key stakeholders
Strong interpersonal and communications skills - confident and capable in a customer facing role
Demonstrate proactive and strategic thinking
Strong oral and written skills

Forward resume directly to me
My Very Best
Eric Lyublinsky
Valintry services
407-205-1125 Direct Line

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