Our Client Company is an innovative, medical device company with a patent-protected portfolio of products representing game-changing technology within the market for pre-filled syringes and other advanced drug- delivery systems for injectable drugs. They are currently seeking motivated, high-potential candidates for Quality Engineer positions in York or Radnor, PA. The salary is $65k - $130k with relocation available.
The Quality Engineer serves as GMP champion throughout the design and development process, identifies critical design parameters through risk analysis, and develops test methods and writes protocols to characterize design parameters. He/she oversees technician execution of test protocols, analyzes data, and writes test reports, and oversees/supports verification and validation activities for new product development. Finally, this position provides domain expertise to the product development team in statistical sampling and analysis, and assumes ownership of the Design History File, Design Master Record, and Device History Record for the team portfolio. Requirements: A Bachelor's degree (or higher) in manufacturing engineering or mechanical engineering, and 3-5 years of experience as a quality engineer in the development of new medical products. Test method development and execution, including experience with metrology, GD&T, and mechanical testing. Experience with mechanical testing instrumentation (e.g., Instron, Zwick) also desired. Knowledge of transfer-to-manufacturing, manufacturing processes, medical device regulations, FDA submissions, testing, and planning. A background in pharmaceutical and/or medical device industry with experience in the development of combination products. Ability to make independent decisions and successful track record of influencing key stakeholders. Strong interpersonal and communication (both oral and written) skills. Comfort with working in a dynamic, multi-skilled environment with a focus on technical excellence, responsiveness to the customer and innovative thinking.
Market-competitive salary (based on skills and experience), and a generous employee benefits package that includes health, vision, prescription drug and dental benefits, short- and long-term disability plans, group term life and accidental death insurance plans, a company-matched 401(k) savings plan and additional discretionary contribution, as well as a free onsite Fitness Center.
Must be a U.S. citizen or Green Card holder.
Interested and Qualified, or do you know someone who might be? To apply, please click on the following link and email your updated resume in Word format, *highlighting the necessary requirements* and indicating position of interest with Quality Engineer - UCQE in the subject line. RCI Recruitment Solutions is a privately owned firm headquartered in Jupiter, Florida, with operations throughout the United States. For almost 40 years, RCI has provided a wide range of candidate sourcing and related recruitment services. Its proprietary and client-specific solutions encompass a variety of services, including advertising, consulting, media services, and staffing technology.