RESPONSIBILITIES
-Ensure suppliers are clear on all Company and International standards, processes and procedures as they relate to various medical devices.
-Perform in line and finished product verification in accordance with Company and International Standard to ensure acceptable -quality.
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-Work with other functional team (QA and PM) to determine appropriate testing parameters for the products to ensure limited failures in product.
-Perform process audits and identify opportunities for continuous improvement on process control, production control and quality control.
-Be responsible for projects with vendors from a quality perspective, more specifically, on product design change, quality performance improvement, and monitoring quality performance on critical products.
-Work with Suppliers and Company corporate office in US to help resolve various customer complaints. Specifically, help with root cause investigations and analysis. -Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.
-Work with suppliers and Company QC team in China to reduce product rejections.
-Work with suppliers to identify opportunities for product and process improvements that lead to cost savings.
-Work with supplier to validate and optimize the production parameters and ensure suppliers properly document and verify these parameters once implemented.
QUALIFICATIONS
-B.S. Degree in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.
-3+ years of engineer experience, project management is preferred
-Understanding of quality system requirements (ISO 13485 or ISO 9001)
-Ability to read and interpret product specifications and drawings
-Detail oriented with strong written and verbal communication, problem solving, and organizational skills
-Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.
-Ability to effectively recognize and suggest improvements for finished products, processes and documentation practices to suppliers, managers, and coworkers.
-Proficiency of PC skills:
AutoCAD or SolidWorks, MS Word, MS Excel, Adobe and E-mail
-Available to travel frequently.
-Excellent English speaking, reading and writing skills.
-Capable of handling special projects as directed by Managers.
