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    http://www.ihireengineering.com/PremiumJobResponse.aspx?PJobID=7977113&Campaign=CareerJet

    This position is being advertised by a number of recuitment companies in the USA it is dated as 11 October It is not listed on the Unilfe medical site however the description of the company would seem to be close to Unilife

    Note this part

    The Company's team is preparing to enter into a new phase of business expansion and is accelerating contracts with pharmaceutical companies, and driving commercialization of a number of key pipeline products currently under development.



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    Job Title:Principal Quality Engineer, Medical Device
    Company:Scientific Search
    Location:York, PA

    . :::::::::::: Principal Quality Engineer, Medical Device Our Client is an innovative medical device company focused on the design development and manufacture of drug delivery devices. This NASDAQ-traded and U.S.-based company is driven by an entrepreneurial spirit and shared passion for the company's products and their potential to save human lives. The Company's team is preparing to enter into a new phase of business expansion and is accelerating contracts with pharmaceutical companies, and driving commercialization of a number of key pipeline products currently under development. Location: Philadelphia Area Summary: 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. Responsibilities: : Serve as GMP champion throughout the design and development process with both internal and customer technical teams : Identify and ensure compliance with relevant domestic and international pharmaceutical and device standards and guidelines : Support design engineers in identification and evaluation of material vendors : Oversee and prepare reports in support of verification, validation, and post market surveillance activities : 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 Requirements: The candidate must have a degree in industrial engineering, manufacturing engineering, mechanical engineering or related field OR hold a Certified Quality Engineer (CQE) Certification (Bachelors required, advanced degrees a plus). The candidate's skills will include some, or all, of the following: : Significant experience 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 : 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 For more information or immediate consideration, please contact: Lisa Marie Missigman, CPC Senior Executive Recruiter SCIENTIFIC SEARCH - Celebrating 28 years and recognized for excellence by the PHILADELPHIA Business Journal, Inc. 5000 & NJBIZ [Register to view] Phone [Register to view] ext 102 www.scientificsearch.com
 
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