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R&d Quality Manager Job In King Of Prussia, Pennsylvania, Eteam Inc.

Published 2022-08-06
Expires 2022-09-06
ID #1117036319
Free
R&d Quality Manager Job In King Of Prussia, Pennsylvania, Eteam Inc.
United States, Pennsylvania, King of Prussia,
Published August 6, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: R&d quality manager


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Description

Job Title: R&D Quality Manager



Duration: 11+ Months contract on W2



Location: King of Prussia, PA 19406



Duties:



The purpose of the Sr. Quality Assurance Engineer is to execute various quality activities per client established quality management system (QMS) and risk management tools and in accordance with 21 CFR Part 820, ISO 13485, EU MDR 2017/745, customer requirements, and applicable standards and regulations. This role supports the client's medical device product development team.



Member of design and development teams and performs quality engineering related tasks. Examples of task include:



Participate in the creation and execution of functional/design requirements.



Support risk management activities including creation of plans. reports. and FMEAs.



Support and approve design verification/validation activities.



Assist in the application of statistical methods.



Participate in design reviews.



Assure cascading of critical to quality features throughout design transfer.



Assures device design is correctly transferred to contract manufacturers.



Assures acceptance activities (receiving, in-process, final) are properly defined and executed.



Compiles data/reports for input to Management Reviews.



Assists QA Associate Director Devices in the management of corrective & preventive actions (CAPA)



Know and follow all laws and policies that apply to one's job, and maintain the highest levels of integrity, ethics, and compliance at all times.



Additional duties as assigned.



Skills:



Min 7 years in medical device quality assurance, manufacturing, or product development



Medical device experience required



Knowledge of 21 CFR Part 820, ISO 13485, and Medical Device Regulation



Excellent customer service focus and professionalism



Proven track record of leading and managing quality or manufacturing initiatives in medical device and supplier relationships with component or contract manufacturers.



Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.



Excellent verbal and written communication skills



Education:



Bachelor's preferred



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    Employer's info

    Eteam Inc.
    Registered on October 7, 2017

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    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.


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