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Quality Assurance Team Lead

Company: Barrington James
Location: Rock Hill
Posted on: November 21, 2022

Job Description:

-New Opportunity- A industry leader provider in the design, development and manufacturing of drug delivery systems is looking for a Quality Team Lead. You would be responsible for supporting Design Transfer and Product Care activities through the application of Quality Engineering skills for medical devices. The successful candidate will handle projects and tasks from product and process inception through to launch and play an active role in processes to make sure products meet quality standards while meeting design control and other regulatory requirements such as: 21 CFR 820, ISO 13485 / 14971 / 11608. Responsibilities: Oversee Quality Engineering, Manufacturing Quality Assurance and Quality Control Teams Ensure that related design control and other projects meet applicable requirements Develop Quality plans and work further with Manufacturing on the transfer of Quality Requirements Decides on material disposition in case of deviations Ensure proper design and development of documentation as per regulations promotes Continuous improvement and Lean Manufacturing processes Requirements: Bachelor's in a Technical / Scientific Degree Experience in a Management Position 5 years' experience in Product Development / Design Assurance in a regulated environment cGxP knowledge of regulations: ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC Experience in modular automation / fully automated assembly processes. English - Mandarin is a plus International travel 10% - first 6 months in Taiwan If you're interested in hearing more, or think you'd be great for this opportunity, please apply or get in touch Email: Tel: (646) 415 8221

Keywords: Barrington James, Rock Hill , Quality Assurance Team Lead, Other , Rock Hill, South Carolina

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